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Baby Formula Recalls [Updated 2024]

Baby Formula Recalls [Updated 2024]
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The latest baby formula recall information to keep your family safe

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 infant formula recalls. 

A recall may happen for various reasons, such as contamination or inaccurate labelling, 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 formula recalls that have happened over the years. But first it’s important to cover some information about recalls so you know what to look out for as a parent.

Frequently asked questions on formula recalls

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 infant 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 infant 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

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. 

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 [email protected] 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?

Little Oak Goat Milk Formulas
  • 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.

Little Oak company website

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 [email protected] or through their website contact us page.

Sources: 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

FDA warning letter infant formula brands

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 [email protected]

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 [email protected] 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 Baby 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.

ByHeart

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 infant formula can and serial number
Source: FDA

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 [email protected] 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.

Further research on baby formula

If you are looking for some reliable formula options and replacements (some that have NEVER been recalled), check out some of our guides and reviews below:

Other baby recall to monitor

Here are some other lists of the top product recalls:

Pre-2022 Baby Formula Recalls

Able Group Formula Recall [August 2021]

Able Group is recalling the following formulas due to low levels of iron and not meeting other FDA criteria:

HiPP Formula Recall

  • HiPP Anti-Reflux Milk Formula
  • HiPP Comfort Milk Formula
  • HiPP Stage 1 Combiotic Infant Milk Formula
  • HiPP Stage 2 Combiotic Follow-on Milk Formula
  • HiPP PRE Combiotic Infant Milk Formula
  • HiPP Stage 1 Combiotic Infant Milk Formula
  • HiPP Stage 2 Combiotic Follow-on Milk Formula
  • HiPP Stage 1 Combiotic Infant Milk Formula
  • HiPP Stage 2 Combiotic Follow-on Infant Milk Formula

Holle, Lebenswert, Kendamil Formula Recall

  • Holle Bio Stage PRE Organic Infant Milk Formula
  • Holle Bio Stage 1 Organic Infant Milk Formula
  • Holle Bio Stage 2 Organic Follow-on Milk Formula
  • Holle Goat Stage 1 Organic Infant Milk Formula
  • Holle Goat Stage 2 Organic Follow-On Infant Milk Formula
  • Holle Goat Stage 3 Organic Toddler Formula
  • Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula
  • Lebenswert Anfangsmilch Stage 2 Organic Follow-on Milk Formula
  • Kendamil Organic Stage 1 First Infant Milk Formula
  • Kendamil Organic Stage 2 Follow on Milk Formula

All of the products manufactured in 2021 have been recalled, so if you’ve purchased any of these, make sure you dispose of them and for more questions contact their email [email protected] or call their center at 628-241-7053

Sources: FDA recall announcement


Bobbie Formula Recall [June 2019]

Last updated April 7, 2020

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

Designed By Nature’s Formula Recall [June 2021]

Designed by Nature has issued a voluntary nationwide recall for it’s milk powder formulas, specifically the Base Milk Powder, Cow’s Milk Powder, and Goat’s Milk Powder.

The main reason for the recall is around labeling as the products were not designed for infant use. This is defined as infants “under a year old” as the formulas are deficient in key nutrients required for labeling as “infant” formula.

What to do? If you purchased these formulas for an infant (0-12 months), you can email “[email protected]” for a refund, or if you have any other questions.

Sources: FDA recall announcement


SMA Wysoy Infant Formula Recall [March 2021]

The following formula by Nestle has been recalled due to blue plastic being found in the package. The following batches have been contaminated (025057651Z, 025057652Z, and 025157651Z) which are best before June – September 2022. In case you have purchased any of these batches, you should contact the company at 0800 081 8180 and they will provide a full refund.


Kirkland Signature Baby Formula Recall [Oct 2019]

Costco store is recalling their generic line of Kirkland Signature brand Non-GMO baby formula (powdered infant formula), due to likely contamination with Cronobacter sppThis is listed as a potential causative agent for meningits and enterocolitis and even sepsis (blood poisoning) in infants.
UPC’s in question are:

  • 0 96619 26926 6 [Kirkland Signature Non-GMO Infant Formula for Babies Sensitive to Lactose]
  • 0 96619 23600 8 [Kirkland Signature Non-GMO Infant Formula for Babies Sensitive to Lactose (2-Pack)]

The findings and initial food recall warning alerts were initially reporting by the Canadian Food Inspection Agency (CFIA), prompting the action to recall.


Calcilo XD Formula Recall [Sept 2019]

calcilo formula recall

On September 13, there was a recall made from Abbott concerning their infant formula Calcio XD due to inconsistency in color. Even though there are no reported cases of babies suffering from ingesting the formula, the company has decided to recall all batches with UPC 0 70074 53329 2.

This product should not be consumed due to rancidity in color and because it can cause diarrhea, vomiting and nausea, so if you have it at home, you should not use it!

  • United States: 1-800-850-7677
  • Canada: 1-855-733-4201

Parent’s Choice Formula Recall [June 2019]

parent's choice formula recall
June 21, 2019 – Perrigo (which owns the Parent’s Choice brand of formula), issued a formal recall on the Parent’s Choice Advantage with Iron formula, as of June 21st, 2018.

The recall notes the “presence of foreign metal material” without going into detail on what this potential presence of metal foreign matter is. Sold exclusively at Walmart, you likely wouldn’t have purchased this elsewhere.

Consumers should specifically look for Lot Code C26EVFV if they suspect their product may be included in the recall.

Sources: FDA recall announcement


Aptamil Powdered Baby Milk Formula Recall

Aptamil Powdered Baby Milk
Changes are not always good, and the proof for that is the new Aptamil Powered Baby Milk formula. Ever since they made slight changes in the product, parents have been complaining that their newborns are showing signs of being unwell and unsettled.

Also, some of these parents are concerned with the new package that is 100g. less than the original one and with still remaining price. The company has explained that their new products are a little bit more sensitive to temperature, therefore, parents would need to make the formula for their babies in a different way.

The formula is still available on Amazon and many other shops, but if you are not certain if you want to take risks with your little one, there are definitely some other options available.


Bebe Mandorle Stage 2 [September 2018]


bebe mandorle stage 2 formula recall
In 2018, Babe Mandorle Stage 2 has been recalled due to contamination with bacteria that could cause serious infection for infants. The formula was sold by the Naturalia chain, and here follow the lots have been compromised.

  • 240 / 7- Best before 02/2020
  • 022 / 8- Best before 07/2020
  • 096 / 8- Best of Date 10/2020
  • 205 / 8- Best of Date 01/2021

Sammy’s Milk Baby Formula Recall [September 2016]

sammy's milk formula recall

Sept. 30, 2016 – All Sammy’s Milk Baby Food powdered formula is recalled because it isn’t manufactured according to federal regulations and has not been tested for Cronobacter, which can cause deadly infections in children.


Sources: FDA recall announcement

Enfamil Baby Formula Recall [December 2011]

enafamil formula recall

Dec. 2011 – Wal-Mart stores removed all cans of Enfamil Newborn formula of one size and from one lot number from shelves (market withdrawal) after one baby died and another became seriously ill from the same bacterial infection (bacterium). This recall is no longer valid.


Sources: CNN


Similac Recall (2010)

Back in 2010, Similac had to recall some Similac powdered infant formula after identifying a common warehouse beetle (both larvae and adults) in the finished product at their Sturgis Michigan plant. This has since been resolved.



Sources: FDA recall announcement | Fortune | Milk Drunk


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  1. Brittany. H. says:

    My son is on Simulac sensitive and I just recently had to give him enfamil inspire witch I could have sworn it was recalled but I can’t find it if it is. I love your website though ! Thanks for all the help

  2. Jessica says:

    Can you find out if there is something going on with honest company formula target, buy buy baby and cvs are no longer ordering it so once there stocks are up they won’t be selling it anymore