The health and wellbeing of your child is undeniably your top priority, and one vital aspect of ensuring this is staying informed about the safety of the products you use daily. This includes being up to date with baby formula recalls. 

A baby formula recall may happen for various reasons, such as contamination or inaccurate labeling, potentially posing serious health risks to your baby. Understanding the implications of these recalls, and acting swiftly upon them, can help you protect your child’s health and assure that they are receiving the safest and most nutritious formula possible. 

We’re here to help make that as easy as possible. Below you’ll find a comprehensive list of all baby formula recalls that have happened over the last few years. But first it’s important to cover some information about recalls so you know what to look out for as a parent.

How often do baby formula recalls happen?

Luckily not very often. There are usually a few every year but most of them are voluntary rather than mandatory. Formula brands know that their reputation (and ultimately their business) is on the line. So if they do not act swiftly and transparently, today’s parents will not stand for that. 

Many people don’t really think of formula as a food, but that’s exactly what it is. So it comes with the same risks that most of our other manufactured and distributed foods come with. 

Why do baby formula recalls happen?

For baby formula, a recall happens when a possible, probable, or potential risk to health is identified. Common reasons behind infant formula recalls include:

• Potential bacterial contamination
• Improper can or container labeling
• Potential inclusions (i.e. plastic, metal)
• Packaging defects
• Inappropriate nutrient levels
• Lack of proper FDA registration

Luckily, when you see a recall it is actually the inherent safety measures actually doing what they are supposed to do. 

What is a “voluntary recall”?

The majority of baby formula recalls are self-initiated by the manufacturer. This means the manufacturer elects to withdraw the product from circulation due to an overabundance of caution, and to advise consumers to discontinue its use based on their evaluation of a possible hazard. On the other hand, a mandatory recall is one where the FDA imposes a halt on the company’s distribution of the product.

Is baby formula regulated in the United States?

Yes, I would say it’s the most highly regulated food in the US. As it should be since it’s the sole source of nutrition for our little ones. 

This means that anything labeled “Infant Formula” (in the USA) is basically the safest food you can purchase in our country which is comforting because even a little tiny infection can have a big impact on a baby.

The FDA inspects all manufacturing plants that make formula, and new manufacturing plants are very carefully inspected and monitored. Manufacturing plants have to stand up to intense safety and monitoring controls and keep rigorous records for every batch made, and all testing results. But accidents happen and this is when recalls are typically announced. 

Keep in mind, the purpose of recalls is to ensure consumer safety 

Although they may seem inconvenient or worrying, particularly when they affect a baby’s only source of nutrition, recalls play a vital role in food safety measures. Given the susceptibility of newborns, it’s crucial for manufacturers to proceed with utmost caution, even if it might cause some dissatisfaction among consumers. 

The wellbeing of infants must always be paramount, even if a recall might present a hurdle for parents. The existence of recall protocols within wider food safety regulations should provide parents with the confidence to utilize formula to nourish their babies, if needed or preferred.

So now that you know a bit more about recalls, why they happen and how the industry is regulated, let’s make sure you’re across all the latest baby formula recalls. 

2024 Baby Formula Recalls

Perrigo Company – Infant Premium store-brand formula sold at CVS and HEB [Aug 2024]

Original recall notice August 8, 2024

Perrigo Company plc is issuing a voluntary recall at the retailer and warehouse level of three lots within one batch, or 16,500 cans, of store brand Premium Infant Formula with Iron Milk-Based Powder due to levels of Vitamin D above the maximum level permitted. The recalled product was shipped to H-E-B Grocery Company, LP in TX ; and CVS in the following states: TX, FL, CA, SC, VA, IN, TN, NJ, MI, PA, RI, MO. No other products or retailers are impacted by this recall.

The Company is initiating this voluntary recall in consultation with the U.S. Food and Drug Administration (FDA). There have been no reports of adverse events to date attributed to the elevated levels of Vitamin D in the product subject to this recall, which was determined through routine testing.

CVS issued a statement to MySA on Friday, July 9, that says that the company is cooperating with the voluntary recall and the product is being removed from CVS Pharmacy stores and CVS.com, and that employees will be given a “Do Not Sell” register prompt in the event a product is rung up to be sold. A CVS spokesperson said that no other CVS-brand infant formula product were impacted by the recall and that no reports of adverse health conditions have been reported. 

What are the health risks?

For the vast majority of infants, short-term consumption of the affected lot codes is unlikely to cause adverse health implications. In a small subset of physiologically vulnerable infants (e.g., impaired renal function), there is the potential that consumption of the recalled product could result in health complications. Parents and caregivers who may have purchased the product should look for the lot codes below with “use by” dates, which can be found on the bottom of the package and should contact their health care provider if they have any concerns.

What products are impacted?

Perrigo has taken immediate action by notifying H-E-B Grocery Company, LP and CVS directly and asking them to examine their retail and warehouse inventory and isolate the product. Parents and caregivers who may have purchased the product should look for the lot codes below with ‘use by’ dates, which can be found on the bottom of the package.

Product shipped to CVS beginning February 6, 2024, being recalled:

• LOT: T11LMYC (USE BY 11NOV2025)

Product shipped to H-E-B beginning February 2, 2024, being recalled:

• LOT: T11LMXC (USE BY 11NOV2025)
• LOT: T09LMXC (USE BY 09NOV2025)

No other lot codes are impacted by this recall.

What you should do if you purchased the product

If infants experience any symptoms while using the product, report them to the FDA’s MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm. Additionally, please contact your healthcare provider.

Any questions or concerns regarding the recall or adverse events associated with these lot codes can be communicated to Perrigo Consumer Affairs at 1-800-538-9543, M-F from 8:00am-5:00pm EST.

How to find a replacement formula

Luckily, this is one of the easiest formulas to find since Perrigo manufactures all of the ‘store-brand’ formulas in the US. So if you bought one of these formulas and need an exact replacement, you can find it at big retailers like Walmart (Parent Choice Infant Premium), Amazon (Mama Bear Infant Premium), Target (up & up Infant Premium) as well as other regional grocery and pharmacy retailers. 

Sources: FDA Announcement

Mt. Capra Goat Milk Formula Recipe Kit [May 2024 & June 2024]

Updated Recall Notice: June 12, 2024

The Mt. Capra Goat Milk Formula Recipe Kit which was pulled from store shelves last month has now been categorized by the U.S. Food and Drug Administration (FDA) as a Class 1 recall, the agency’s most severe level of concern pertaining to product removal.

The FDA this year has issued more than 500 Class 1 recalls. A Class 1 is defined as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death,” according to the FDA website. Class 1 recalls are especially concerning when children are involved, and the FDA is urging parents to immediately dispose of the baby formula in question or risk their infant’s health.

Original Recall Notice: May 11, 2024

Mt. Capra Products of Chehalis, Washington, recalled 1,506 boxes of their Goat Milk Formula Recipe Kit (10-pound, 8-ounce items). The FDA is “concerned that the formula does not meet all FDA requirements for infant formula, does not provide sufficient nutrition when used as an infant formula, and the storage instructions may be insufficient for the product.”

The FDA advises consumers to immediately discontinue use of the product, which is sold online and in one retail location in Chehalis, between May 1, 2023, and May 1, 2024.

Despite what you may see on social media and other platforms from parents, it is advised that infants ages 0-12 months should not consume the product.

The FDA notified Mt. Capra of an “adverse event report of anemia” in one infant. However, it was later determined that the use of the recipe kit was done along with the substitution of some ingredients with a different brand of multivitamin, which reportedly led to a deficiency of vitamin B12 as well as folate. This contributed to the illness.

The product’s case has one of the following affected lot codes, which is affixed to the case as seen in the below image: 13150423, 13150723, 13151223, 13151323, 13151623, 13151823, 13151923, 13152123, 13152423, 13152523, 13152623, 13152823, 13153023, 13153123, 13153423, 13153523, 13153723, 13153923, 13154123, 13154423, 13154523, 13154723, 13154923, 13155023, 13155223, 13150124, 13150424, 13150624, 13150924, 13151024, 13151124, 13151224, 13151424, 13151624, 13151724, 13151824.

Customers are advised to destroy or return the product. Concerns can be relayed to Joe Stout at (360) 748-4224 or by email to orders@mtcapra.com.

Sources: FDA Announcement, Newsweek, FDA 

Dairy Manufacturers inc – Farmalac and Crecelac Formula Recall [May 2024]

Updated recall notice August 8, 2024

The FDA has discovered new potential health risks in the recently recalled Crecelac baby formula, specifically high levels of potassium and chloride, which could lead to kidney and heart issues in infants. Additionally, the formula was found to have low levels of Vitamin A, potentially causing vision problems. These findings were not part of the original recall concerns. The FDA urges families to discontinue use immediately.

Original recall notice May 24, 2024

The FDA is alerting parents and caregivers about safety concerns related to Cronobacter contamination in Crecelac Infant Powdered Goat Milk Infant Formula and other products from Dairy Manufacturers Inc. The recall was voluntarily initiated on May 24, 2024, due to non-compliance with FDA regulations, with Cronobacter found in a sample on May 29, 2024. Current Situation: No illnesses have been reported, and the recall is not expected to impact the supply of infant formula.

Products Recalled:

Cronobacter Risks: Cronobacter can cause severe infections in infants, including bloodstream infections, meningitis, brain abscess, developmental delays, motor impairments, and death.

Symptoms in Infants:

• Poor feeding
• Irritability
• Temperature changes
• Jaundice
• Grunting breaths
• Abnormal body movements

What you should do if you purchased the product

Parents and caregivers are advised not to feed the recalled formulas to infants. If an infant shows symptoms of Cronobacter infection, contact healthcare providers immediately. For alternative goat milk infant formulas, consult healthcare providers. More information on safe feeding practices can be found on the FDA’s infant formula landing page.

The FDA is working with the firm to ensure the recall is effectively executed and advises parents and caregivers to stay informed for the safety of their infants.

Consumers who have purchased Crecelac Infant 0-12, Farmalac 0-12 and Farmalac 0- 12 low lactose are urged to discontinue use of the recalled products and return it to the place of purchase for a full refund. There have been no known reports of injuries or adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

Consumers with questions may contact the company at 1-972-347-2341 (Monday to Friday, 9:30 a.m. to 5 p.m. EST).

Sources: FDA Alert, FDA Announcement, Drugwatch

Enfamil Nutramigen Powder [Dec 2023]

On Dec 31, 2023 the FDA announced infant formula manufacturer, Reckitt/Mead Johnson Nutrition (MJN), has voluntarily chosen to recall select batches of Nutramigen Hypoallergenic Infant Formula Powder, a specialty infant formula for the dietary management of Cows Milk Allergy (CMA) in 12.6 and 19.8 oz cans from the U.S. market.

TLDR – The test came from an exported batch that was sampled at the Israeli border. There are no reports of illnesses or adverse events to date in the US at this time. Based on the limited availability of the remaining stock of this special infant formula, it is believed that much, if not all, of the products recalled in the United States have been consumed already.

The products were manufactured in June 2023 and distributed primarily in June, July, and August 2023. The products were distributed through retail stores nationwide. The batches in question can be identified by the batch code on the bottom of the can.

The following recalled product batch codes and can size associated with each batch were distributed in the U.S.:

• ZL3FHG (12.6 oz cans)
• ZL3FMH (12.6 oz cans)
• ZL3FPE (12.6 oz cans)
• ZL3FQD (12.6 oz cans)
• ZL3FRW (19.8 oz cans)
• ZL3FXJ (12.6 oz cans)

The products have a UPC Code of 300871239418 or 300871239456 and “Use By Date” of “1 Jan 2025”. No other U.S. distributed Nutramigen batches or other Reckitt products are impacted.

What you should do if you purchased the product

Consumers who purchased Nutramigen should check the bottom of the can to identify whether the batch number is affected. Products with the batch codes listed above should be disposed of, or contact Enfamil for a total refund. Please contact us at 866-534-9986 or by email at consumer.relations@rb.com and they will help verify if this product was impacted. 

What to do if you need a substitute hypoallergenic formula

Hypoallergenic formulas can be hard to come by right now and the options are limited. We’ve recently updated our best hypoallergenic formulas list if you’re looking for an alternative. 

2023 Baby Formula Recalls

No Recall – 2 Cronobacter Sakazakii Cases Raise Concerns About Powdered Baby Formula Safety [Nov 2023]

The bacteria responsible for the 2022 baby formula recall, Cronobacter sakazakii, has resurfaced in 2023, causing tragic consequences for infants in Kentucky and Missouri. Federal health officials have reported two cases of life-threatening infections linked to powdered formula manufactured by Abbott Nutrition, the company involved in the previous recall.

TLDR: The FDA has stated there is currently no broader public health concern related to the products linked to these 2 infants.

In February 2022, Abbott initiated a voluntary recall of its powdered baby formulas, including popular brands such as Similac, Alimentum, and EleCare. The recall was prompted by the presence of Cronobacter sakazakii found at one of Abbott’s facilities in Sturgis, Michigan. This rare bacteria, known to be lethal to infants and serious in those with immunocompromising conditions, led to shortages and widespread concerns across the United States.

The recent cases in 2023 involved a newborn in Kentucky who tragically lost their life and a Missouri infant suffering brain damage after consuming Abbott Nutrition’s powdered formula. Both Abbott and the FDA have, however, found no evidence linking the contamination to the formula maker’s facilities. Investigations suggest that the contamination likely occurred after the formula containers were opened at home, emphasizing the crucial importance of proper handling.

The FDA, after the investigation, stated that there is no reason for new recalls for baby formula, as the recent infections were not linked to manufacturing. Abbott officials reiterated that the reported infections in Missouri and Kentucky have not been connected to the company’s manufacturing facilities. The FDA emphasized that there is currently no broader public health concern related to the product.

In March, a 6-week-old baby in Missouri named Mira White faced severe brain infection from Cronobacter sakazakii found in an open container of Similac NeoSure formula at home. Similarly, in Kentucky, a baby consuming Similac Total Comfort powdered formula lost its life after contracting the bacteria. These heartbreaking incidents underscore the urgent need for increased awareness and caution among parents.

Cronobacter sakazakii is a naturally occurring germ found in the environment, especially in dry foods like powdered infant formula and powdered milk. The CDC emphasizes the importance of cleanliness to reduce the risk, advising parents to frequently clean surfaces, hands, and baby products. Additionally, parents are urged to avoid placing formula scoops on countertops, keep lids and scoops clean and dry, and promptly close formula containers after use.

As the bacterial threat resurfaces, parents are encouraged to stay informed and adhere to stringent hygiene practices when handling powdered infant formula, prioritizing the health and safety of their little ones. The recent cases serve as a stark reminder of the potential risks associated with contaminated formula, highlighting the need for continuous vigilance and proper handling procedures.

Sources:

Hindustan Times, Pipanews and Newsweek

Little Oak Goat Milk Formula Recall [Sept 2023]

Last updated Sept 19, 2023

Little Oak is a newer player in the formula space and had recently started selling their infant and toddler formulas to US customers. They are a smaller company from New Zealand producing some amazing goat milk formulas but as you can read more about below, the company has issued a voluntary recall of their formulas.

Directly from the FDA press release

Little Oak infant formula was sold without the submission of a required premarket notification to the FDA and, therefore, has not been evaluated to determine whether the product meets U.S. food safety and nutritional standards. The FDA has communicated to the firm that they have not met the requirements for selling infant formula in the U.S., and on September 9, 2023, the firm agreed to voluntarily recall the affected products and cease sale and distribution of infant formula to the U.S. until the firm has met the requirements to do so.

Previously, in 2022, the LittleOak Company requested enforcement discretion to be able to sell infant formula in the U.S. temporarily. The FDA deferred consideration of their request because of concerns regarding the preparation instructions on the product labels, among other reasons. In addition, the FDA had questions about two ingredients in their infant formulas that have not yet been evaluated by FDA to determine if they are safe to use in infant formula.  The FDA did not believe these issues could be resolved quickly to help meet the need during the infant formula shortage, and ultimately did not issue a letter of enforcement discretion to the LittleOak Company.

What products are impacted?

• LittleOak Natural Goat Milk Infant Formula
• LittleOak Natural Goat Milk Follow-on Formula

Little Oak is a small boutique formula manufacturer that really cares about their products and the families that have grown to depend on them. They left a note for parents on their website after the event. 

A note to our US families

During the infant formula shortage in the US, we saw many US families reach out to us here at LittleOak New Zealand to provide them with critical nutrition for their child. 

As a result of this overwhelming support, we began the process to secure FDA approval for our LittleOak infant formula range (LittleOak Infant Formula (Stage 1) and LittleOak Follow-On Formula (Stage 2)). 

Sadly, while our application is still in process, the FDA has requested us to stop selling our infant formula products to US families through our global online channel while we complete the pre-market approval, which primarily focuses on creating US FDA compliant labelling. We have agreed with the FDA and will focus our full efforts to obtain FDA approval of our infant formulas as quickly as we can, so we can make our products available again to US families as soon as possible.

It leaves us in an absolutely heartbreaking position where we have no choice but to immediately stop providing US families with LittleOak formula– a formula that we know many of you have come to rely on. 

It is important to note that this decision is not a quality or safety issue, but more a compliant labelling matter. LittleOak has been nourishing children for years and feeds millions of infants and babies across the globe every day, and will continue to do so. LittleOak is proudly manufactured in New Zealand, which has the highest production and quality standards anywhere in the world, including the US. Again, this is not a safety or quality issue, but rather part of a regulatory process we must abide by.

Despite the recent news, we absolutely remain committed to supporting American families. This decision does not affect our LittleOak Toddler Milk. In fact, we will shortly start manufacturing in the US, with a FDA compliant LittleOak Toddler Milk (Stage 3) rolling off the production line and available for US families in the coming months. 

We know this isn’t the news families want or indeed should hear, and we’re truly sorry for the impact this will have. 

What you should do if you purchased the product

If you have any questions or need support, please do get in touch with the LittleOak Careline team at hello@thelittleoakcompany.ca or through their website contact us page.

Source: FDA, LittleOak

Parents Choice Sensitivity Premium & Tippy Toes Sensitivity Premium [Sept 2023]

Last updated Sept 11, 2023

Parent’s Choice Sensitivity Premium Infant Formula and Tippy Toes Sensitivity Premium Infant Formula are being recalled. They were released after being rejected during some part of the product testing process. There was no specific reason provided for why the formula was rejected. 

The recall initiation date was back in June 16, 2023, but the classification date was not until September 6, 2023.

Because this recall notice was posted on the FDA’s Enforcement Report page instead of the regular recall page, there is no mention of whether or not any illnesses have been reported to the company to date in connection with the consumption of these infant formulas. The recalling firm is PBM Nutritionals, LLC of Georgia, Vermont.

The product was shipped to these states: IL, AL, IA, GA, MS, IN, AR, CO, FL, VA, OH, WI, PA, NH, AZ, KS, TX, TN, NC, LA, MO, KY, DE, WI. So if you live in one of these states and buy Parent’s Choice Sensitivity Premium or Tippy Toes Sensitivity Premium, please carefully inspect your formula tubs.  

The recalled products are Parent’s Choice Sensitivity Premium Infant Formula that is packaged in 638 gram plastic tubs. Also recalled is Tippy Toes Sensitivity Premium Infant Formula that is packaged in composite cans, with a package weight of 942 grams. The code and use by date pairs for these products are D05LVJV and USE BY 05MAR2025, and D06LT7VA and USE BY 06MAR2025. The UPC numbers for these items are 36800496644 and 681131045513.

If you purchased either of these infant formula products, do not feed them to your child. 

You can throw them away in a secure trash can after first double bagging them, or you can take them back to the store where you bought them for a full refund. 

We don’t have any other information at this time but will update this section if more information is released. 

Sources: FDA

FDA sends warning letters to formula companies [August 2023]

Last updated Sept 8, 2023

On August 30, 2023 the FDA issued warning letters to three infant formula manufacturers, ByHeart, Reckitt/Mead Johnson Nutrition, and Perrigo, as part of their ongoing efforts to help ensure that the industry is producing infant formula under the safest conditions possible.  

Let’s be really clear, this is not a recall. The FDA is not advising parents or caregivers to throw away or avoid buying any particular infant formula.

According to the FDA, it oversaw each company as it conducted recalls in December, February and March to remove formulas potentially contaminated with Cronobacter sakazakii.

The FDA said it issued the warning letters to the three manufacturers on Wednesday to reinforce “the importance of instituting and maintaining appropriate corrective actions when they detect pathogens.”

The manufacturers must investigate to determine the root cause of any prior contamination and perform cleaning and sanitation activities. It is also being recommended they also then evaluate their cleaning and sanitation practices, schedules and procedures before releasing formulas.

This is good news coming out of a bad situation. The FDA seems to actually be taking this quite seriously and following through. This is the most important food on the planet and it should be treated that way. 

Sources: FDA infant formula strategy, ByHeart update, Daily Reporter

Nutricia TYR Anamix Early Years Recall [May 2023]

Last updated June 21, 2023

Nutricia North America is recalling 94 cans of TYR Anamix Early Years infant formula because the product contains undeclared tyrosine, a nonessential amino acid.

There isn’t nearly as much information about this recall as you typically see from other recalls. It was initially reported by FoodSafetyNews in May but has been updated by the FDA in June 2023. According to the details published online by the FDA, the recall is ongoing.

Details of the Nutricia North America TYR Formula Recall

The recalled products were distributed in Alaska, California, Connecticut, Florida, Illinois, Kansas, Louisiana, Maine, Minnesota, Mississippi, Nebraska, New Mexico, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Puerto Rico.

Recalled product:

• Net Wt. 14.1 oz (400g) 
• UPC: 749735002186 
• Product is a powder packed metal cans. 6 cans per case.
• Expiration date: 03/30/2024 
• Batch/lot code 101175408 
• Case EAN code: 749735102183 
• Vendor product code: 90218

What you should do if you purchased the product

Anyone who purchased the recalled product should immediately dispose of it and not consume it. There has been no information reported about how to claim a refund. We will post it if that information becomes available.

Sources: Food Safety News press release | FDA announcement | Food Industry Council recall notice

Gerber Good Start SootheProTM Powdered Infant Formula [March 2023]

Last updated: May 19, 2023

On March 17, 2023 Perrigo, the new manufacturer that now products all Gerber Infant Formula issued a voluntary recall on some of their powdered infant formulas out of an abundance of caution. 

That means none of the formula has actually tested positive for the bacteria they are concerned about and there have been no reported illnesses but it’s best to be cautious and avoid this formula.

Read more below to find out what products were impacted, where they might have been sold, what to do if your baby has consumed any of this formula and how to claim a refund.

Details of the Gerber Formula Recall

The text below is directly from the FDA recall notice. 

Perrigo Company plc is issuing a voluntary recall of certain lots of Gerber® Good Start® SootheProTM Powdered Infant Formula in the U.S., that were manufactured at the Company’s Gateway Eau Claire, Wisconsin manufacturing facility from January 02, 2023 to January 18, 2023. This product is being recalled out of an abundance of caution due to the potential presence of Cronobacter sakazakii

Importantly, no distributed product has tested positive for the presence of this bacteria, no adverse events have been reported and no other products manufactured at this facility or any other of Perrigo’s facilities are affected by this recall.

Cronobacter sakazakii is a bacteria commonly found in the environment. In most people it causes no symptoms but in some, particularly premature infants, infants under 2 months of age or infants with weakened immune systems fever, poor feeding, excessive crying or low energy as well as other serious symptoms can occur.

This product is sold at retailers across the U.S. Consumers who purchased the product after March 5, 2023 should look for the following Lot Codes and “use by” dates, which can be found on the bottom of the package. No other lot codes are impacted by this recall. Any consumers who purchased product with matching codes should discontinue use and dispose of the product.

Gerber® Good Start® SootheProTM 12.4 oz:

• 300357651Z – USE BY 04JUL2024
• 300457651Z – USE BY 05JUL2024
• 300557651Z – USE BY 06JUL2024
• 300557652Z – USE BY 06JUL2024
• 300757651Z – USE BY 08JUL2024
• 300857651Z – USE BY 09JUL2024
• 301057651Z – USE BY 11JUL2024
• 301057652Z – USE BY 11JUL2024
• 301157651Z – USE BY 12JUL2024

Gerber® Good Start® SootheProTM 30.6 oz:

• 301357652Z – USE BY 14JUL2024
• 301457652Z – USE BY 15JUL2024
• 301557651Z – USE BY 16JUL2024

Gerber Good® Start® SootheProTM 19.4 oz:

• 301557652Z – USE BY 16JUL2024I

Consumers can request refunds for impacted products and find more information about Gerber® Good Start® by contacting the Gerber Parent Resource Center on behalf of Perrigo at 1-800-777-7690 anytime 24/7. Consumers with any health-related questions should contact their healthcare provider.

This recall is being conducted in consultation with the U.S. Food and Drug Administration (FDA).

Additional information from Gerber 

The text below is pasted directly from Gerber’s website about what products are impacted by the recall and how to provide proof of purchase to claim your refund

Perrigo has issued a voluntary recall of certain lots of Gerber Good Start® SoothePro™ powdered infant formula. Parents and caregivers who purchased the product after March 5, 2023, should look for the following Lot Codes and Use By dates, which can be found on the bottom of the package. No other lot codes are impacted by this recall. Consumers who purchased product with codes matching those recalled should discontinue use and call Gerber Parents Resource Center on behalf of Perrigo at 1-800-777-7690, in order to receive a refund. You will be asked to provide proof of purchase in the format of a photograph that captures the batch codes on the bottom of all impacted cans in your possession in one image.

On May 14, 2023, the FDA reannounced the safety alert because the recalled formula was accidentally sent to eight states by AWG (Associated Wholesale Grocers, Inc.), a cooperative food wholesaler, after the initial recall was made.

Consumers who purchased this product through these retail locations in these states are urged to check any product they may have at home, and look for these lot codes and “use by” dates. You can find the dates on the bottom of the package. Click here for more information about the locations. 

Related recall – Nestlé Good Start Soothe Infant Formula

On March 18th, 2023, Nestlé (who owns Gerber) also recalled 942-gram packages of their Good Start Soothe formula across Canada. The reason for this recall is likely due to the same possible bacteria contamination from the Gerber recall. The lot numbers for the affected packages are: 

• 301757651Z 
• 301757652Z 
•  301857651Z

The best before dates on these formula packages are July 18th and July 19th, 2024. While there are no reported illnesses, Nestlé is encouraging affected customers to contact Nestlé customer service for a refund before throwing the product away. 

Sources: Official Gerber announcement | FDA recall announcement | WSBTV press release | Carolina 7News press release | CDC update on cronobacter | MIBiz article on Perrigo investment | Government of Canada 

Enfamil ProSobee Recall [February 2023]

Last update: February 21, 2023

On February 20, 2023, Reckitt, a producer of nutrition products, announced today that, out of an abundance of caution, it has chosen to voluntarily recall two (2) select batches of ProSobee 12.9 oz. Simply Plant-Based Infant Formula due to a possibility of cross-contamination with Cronobacter sakazakii.

All product distributed went through extensive testing and tested negative for the bacteria. And there have been no reported adverse consumer reactions to date.

Details of the Enfamil Formula Recall

The information below is taken directly from the FDAs recall notice.

ProSobee Simply Plant-Based Infant Formula in 12.9 oz containers was manufactured between August 2022 and September 2022. The products were distributed through retail stores nationwide in the U.S., Guam, and Puerto Rico. The batches in question can be identified by the number on the bottom of the can. Recalled product batches are ZL2HZF and ZL2HZZ both with a UPC Code of 300871214415 and a “Use By Date” of “1 Mar 2024.”  The recall involves approximately 145,000 cans.

No other ProSobee Simply Plant-Based Infant Formula batches or other Reckitt products are impacted. 

No illnesses or adverse events have been reported. If parents have any questions, they should consult with their pediatrician or contact us at 1-800-479-0551 24/7 or by email at consumer.relations@rb.com

What you should do if you purchased the product

Consumers who purchased ProSobee Simply Plant-Based Infant Formula should check the bottom of the can to identify whether the batch number is affected. Product with batch codes ZL2HZF and ZL2HZZ both with a UPC Code of 300871214415 and a “Use By Date” of “1 Mar 2024” should be disposed of or returned to the place of purchase for a total refund. You can also contact us at 800-479-0551 or by email at consumer.relations@rb.com and we will help verify if this product was impacted.

How to determine if you purchased one of these products

There are additional details on the Enfamil website. They say to determine if you have purchased the recalled product you can check any product you have on hand for the below listed recalled batch codes. 

• Product: Enfamil ProSobee Powder, 12.9 oz Can
• Global Batch Code: ZL2HZF
• UPC: 300871214415
• Lot Number: 0670975
• Expiration: 3/1/2024

• Product: Enfamil ProSobee Powder, 12.9 oz Can
• Global Batch Code: ZL2HZZ
• UPC: 300871214415
• Lot Number: 0670979
• Expiration: 3/1/2024

What to do if you have purchased one of the products

If you believe your product is related to this issue, the product should be disposed of or returned to the place of purchase for a total refund. Please contact Enfamil on 1-800-Baby123 or at www.enfamil.com/contact-us/ and they will help verify if this product was impacted.

Sources: Official Enfamil recall notice | FDA recall announcement | CNN reporting on recall 

2022 Formula Recalls

ByHeart Whole Nutrition Formula Recall [December 2022]

Last updated: December 12, 2022

On December 11, 2022, ByHeart, a next-generation baby nutrition company, announced that, out of an abundance of caution, it has chosen to voluntarily recall five batches of ByHeart Whole Nutrition Infant Formula due to the potential for cross-contamination with Cronobacter sakazakii. Luckily no distributed ByHeart product has tested positive for the bacteria.

The possible contamination occurred during the packaging process and they are notifying everyone out of caution. 

Details of the ByHeart Formula Recall

The text below is directly from ByHeart’s recall announcement: 

We have chosen to voluntarily recall five batches of ByHeart Whole Nutrition Infant Formula due to the potential for cross-contamination with Cronobacter sakazakii, a bacteria commonly found in the environment and a variety of areas in the home.

No distributed ByHeart product has tested positive for the bacteria. In addition, we have not received any consumer complaints that would indicate any illness, If your baby has already consumed the formula, there is no reason for concern, and no additional action is needed.It is important to note that this recall is not related to ByHeart’s own manufacturing in any way.

We own our entire manufacturing supply chain with the exception of final canning, which is conducted by a reputable third-party packager. We are taking this precautionary measure because one test sample collected from the third-party packaging facility tested positive for Cronobacter sakazakii.

All product packaged that day, and the first production on the next day, was isolated for destruction and not distributed. None of this product ever was sent to customers.

Out of an abundance of caution, we are now recalling all product produced during the entire production run and will refund all customers who are impacted who have received an order containing a can from any of the impacted batches. 

What to do if you have purchased one of the products

Customers who purchased ByHeart product should check the bottom of the can and dispose of product from these batches:

• 22273 C1
• 22276 C1
• 22277 C1
• 22278 C1
• 22280 C1

No other batches are affected by this. All other batches of ByHeart formula are safe to continue to feed to your baby.

ByHeart is setting up a webpage at https://byheart.com/notices with additional information about its measures. Should customers have any other questions or want to find out if the product they have is included in the voluntary recall, please email notices@byheart.com or text ByHeart at 1-909-506-2354. The company will also be reaching out directly to all customers via email who purchased orders from these identified batches.

ByHeart knows that formula is critical to a baby’s health and growth and wants to make sure that all customers have what they need to keep their baby fed and healthy, no matter what brand of formula they use. While ByHeart works 24/7 to meet the demand for formula, the fastest way the company can replace the formula customers purchased is to cover the cost of two cans of alternate formula. Additionally, affected customers will receive two cans of their next order of ByHeart Whole Nutrition Formula for free.

Sources: FDA recall announcement | ByHeart official press release | Food Safety News press release 

Abbott Similac Ready-to-Feed Formula [October 2022]

On October 17th, Abbott recalled their 2-ounce ready-to-feed formula bottles. Abbott claims some of the bottles weren’t properly sealed, which could potentially cause spoiling. 

Details of the Abbott Similac Ready-to-Feed Formula Recall

Less than 1% of the recalled lots have bottle caps that may not have sealed completely. If children consume products that have spoiled, they could experience vomiting or diarrhea.

Most of the recalled products were distributed to hospitals and to some doctors’ offices and retailers. Abbott said it is producing these products for hospitals and health care providers’ offices from a different production line, and Similac infant formula is available in different product sizes for retail locations.

They recalled the following products: 

• Pedialyte Electroyle solutions 
• Similac Stage 1
• Similac 360 Total Care
• Similac 360 Total Care Sensitive
• Similac Pro-Total Comfort
• Similar Special Care 24
• Similac sterilized water
• Similar Neosure 

There aren’t any liquid or powdered formula recalls included in this. If you have an affected product, Abbott recommends throwing out the bottles of formula. 

What to do if you have purchased one of the products

Health care providers can reach Abbott at 800-551-5838. The general public can contact customer service at 800-986-8540.

Sources: Official Similac recall website | American Academy of Pediatrics 

Abbott (Similac PM 60/40 Low-Iron) Formula Recall [February 2022]

Last updated March 1, 2023

Abbott is voluntarily recalling one lot of Similac PM 60/40 (Lot # 27032K80 (can) / Lot # 27032K800 (case)) manufactured in Sturgis, Michigan. 

This is a related voluntary recall from the one issued on February 17th for lots of Similac, Alimentum and EleCare powder formula. 

The action comes after learning of the death of an infant who tested positive for Cronobacter sakazakii and who we were informed had consumed Similac PM 60/40 from this lot. This case is under investigation, and at this time the cause of the infant’s Cronobacter sakazakii infection has not been determined.

This recall notice is about one specific product — Similac PM 60/40. Only two lot numbers are included in that part of the recall:  27032K80 for individual cans and 27032K800 for cases of Similac PM 60/40.

Please refer to the information in the recall below to read more about this wider recall.

Abbott (Similac, Alimentum, and EleCare) Formula Recall [Feb 2022]

Last updated March 1, 2023

Abbott initiated a proactive, voluntary recall of powder formulas, including Similac, Alimentum and EleCare, manufactured in Sturgis, Michigan, one of the company’s manufacturing facilities. The recall does not include any metabolic deficiency nutrition formulas.

While Abbott’s testing of distributed product detected no pathogens, we are taking action by recalling the powder formula manufactured in this facility with an expiration of April 1, 2022, or later. 

This voluntary recall is what led to a nationwide formula shortage. Below, we’ll cover everything you need to know about the recall — why it happened, which products are recalled, and what to do if you’re having trouble finding your baby’s formula product

Details of the Abbott Formula Recall

Abbott Nutrition has a wide variety of infant formula products. Similac, Similac Alimentum, and Elecare are the brands that have been recalled. But, within each of these brands, there are multiple products. Each product works a little differently or has different ingredients.

For example, Similac products include Similac Advance, Similac Organic, and Similac Pro-Advance — just to name a few. This means the recall includes more products than you might expect. In fact, the recall includes close to 50 individual products.

No liquid formula products are included in the recall.

What you should do if you purchased the product

When you enter a formula product’s lot number on Abbott’s website, you’ll be able to learn if your product is included in the recall. If it is, you’ll be directed to enter more information. Abbott will send you instructions on how to return the product. You can also call Similac customer service at 800-986-8540.

Another option is to return your formula product to the place you bought it from. According to Abbott, this is the fastest way to get a refund.

For more questions about how to get a refund on recalled formula, check out Abbott’s frequently asked questions page.

How to determine if you purchased one of these products

Not all Abbott Nutrition formulas have been recalled. The recall only applies to specific batches (lots) of formula that were made during a given time period. 

The FDA has a list of recalled products on their website. If you determine you have one of these products at home you can check if your product has been recalled on Abbott’s website. You’ll need the product’s lot number to do this.

According to Abbott, the lot numbers are 7-9 digit codes that can be found on the bottom of the formula container. There may be a letter at the start of the code. For example, L31465SH00 contains an “L” before a 9-digit lot number.

If your product is part of the recall, it will meet all three criteria below:

• The first two digits of the lot number start with 22 through 37. This doesn’t include the letter at the start of the lot number, if there is one (e.g. in the lot number L31465SH00, “31” is the start of the lot number).
• The lot number contains one of the following: K8, SH, or Z2.
• The expiration date is April 1, 2022 (APR 2022) or later.

Sources: FDA announcement | Official Similac recall website | 

Conclusion

What to do if your brand gets recalled

While massive recalls on any major baby formula brand are few and far between, there are things that you can do when your brand gets recalled.

1. Check the details. Most brands only recall certain serial numbers. Your brand just might not be on the list.
2. Know that many recalls are ‘safety alert’ precautions, especially when it comes to baby formula. Don’t panic if you do discover that the brand you use has been recalled.
3. Use baby formulas always as directed. If you are not following the exact directions on how to prepare your infant formula, you could cause adverse reactions if there is something in the way you prepared the formula, cleaned the bottles, nipples, etc. Make sure you follow the directions and always sterilize.
4. Keep checking this page (we’ll be updating it as soon as we discover any new baby formula recalls.)
5. Do your research first before investing in any infant formula.
6. If your baby is having any adverse reactions to formula, stop feeding immediately and call your doctor.

Pre-2022 Baby Formula Recalls

Bobbie Formula Recall [June 2019]

Bobbie is one of the newest entrants into the formula market. They were making their formula in Germany at the time because they were trying to match many of the updated nutritional guidelines the European Commission uses to regulate infant formula across the EU. 

In June 2019 the FDA conducted an inspection of Bobbie Baby Inc., and determined that they were “not in compliance with FDA regulations instituted to ensure the health of developing infants who consume infant formula. The firm was inspected under the Infant Formula Requirements (21 Part 106 and Part 107) included in Title 21 of the Code of Federal Regulations.”

The FDA recommended that parents should stop using Bobbie Milk-Based Powder Companion Formula from Bobbie. 

This recall was not due to contamination like many of the other recalls on this list. Essentially this was a labeling recall, FDA has certain regulations that all infant formulas must meet and Bobbie’s was falling short of them. They were following the EC guidelines instead. 

This was a big blow for the startup at the time but they have recovered since and have been doing really well at disrupting the bigger formula incumbents. 

What you should do if you purchased the product

Don’t panic. This is not a recall of contaminated formula that could make your baby extremely sick. This is a difference of opinion between what some people believe is the right around of nutrients for your baby. 

Consult with your pediatrician to learn more about what you need to think about here. 

How to determine if you purchased one of these products

To figure out if you have purchased a product included in this recall please follow the FDA guidelines below:

• Product Name: Bobbie Milk-Based Powder Companion Formula, Net wt. 14.1 oz (400g)
• Packaging: Brown and green cardboard boxes (2, 4, or 8 units per box) with the bobbie logo
• Lot numbers: Codes on the product of concern are; L6236501Z001; Use By: 9.15.2020; L6236501Z002; Use By: 9.15.2020; L6236501Z003; Use By: 9.16.2020; L6236501Z004; Use By: 9.16.2020
• Dates: Product of concern was shipped between the dates of May 12, 2019 and May 30, 2019

Sources: FDA recall announcement | Fortune | Milk Drunk

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