Baby formula recalls

Infant formula recalls in FDA enforcement reports, one entry per recall event.

Updated October 19, 2026 · Source: FDA

Short answer

FDA enforcement reports list 21 infant formula recalls since 2012, most recently nara organics brand on June 13, 2026. 3 were announced in the 12 months to October 19, 2026. The list covers the recalls found in FDA's records, so also search the official database with your lot number.

21 recalls since 2012
3 in the last 12 months
17 brands and companies named
Jun 2026 latest recall

Breast pump flanges in several sizes, two collection bottles and a small measuring tape on a kitchen counter

Every infant formula recall, newest first

Each row links to FDA's notice, which lists the affected models, dates and how to get the remedy.

21 infant formula recallsAs of October 19, 2026

Date	Product	Hazard	FDA class	Units	Official
Jun 13, 2026	Nara Organics a.) nara organics brand; Whole Milk Organic Infant Formula; Milk-based Powder with Iron; 0-12 months; NET WT 24.7 OZ (700 G); UPC: 860013251901 b.) nara… Product may be contaminated with Clostridium botulinum. Units: 377,610 cans	Product may be contaminated with Clostridium botulinum.	Class I	377,610 cans	FDA report
May 1, 2026	The a2 Milk a2 Platinum Premium infant formula Milk-based Powder with Iron 31.7oz (900g) Intended use: infant formula (0 12 months). Possible contamination with Cereulide toxin. Units: 51,202 units	Possible contamination with Cereulide toxin.	Class I	51,202 units	FDA report
Nov 8, 2025	ByHeart 1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 grams; Cans sold in 1 pack, 2 packs, 4 packs, or 6 packs 2. Contaminated with Clostridium botulinum Units: 3,482,131 Cans and 3,531,901 Single Serve Packets.	Contaminated with Clostridium botulinum	Class I	3,482,131 Cans and 3,531,901 Single Serve Packets.	FDA report
Aug 5, 2024	PBM Nutritionals CVS Health brand and HEB Baby brand Premium Infant Formula with Iron Milk-Based Powder; packaged in 964g composite cans; 4 cans per case; UPC 50428318034 and… Product contains levels of Vitamin D above the maximum level permitted. Units: 16,500 units	Product contains levels of Vitamin D above the maximum level permitted.	Class II	16,500 units	FDA report
May 24, 2024	Dairy Manufacturers Farmalac powdered infant formula with iron 12.4 oz cans; Crecelac Infant 0-12 powdered infant formula with iron 12.4 oz cans; Farmalac 0-12 Low lactose… The firm has not submitted the required premarket notification, parents and caregivers should understand that the products have not been… Units: 5376 cans	The firm has not submitted the required premarket notification, parents and caregivers should understand that the products have not been evaluated to determine whether they meet U.S. food safety and nutritional…	Class I	5376 cans	FDA report
May 10, 2024	Mt. Capra Products Mt. Capra Goat Milk Formula Recipe Kit (net wt. 10lbs. 8oz.) and Bundle Refill. The Goat Milk Formula Recipe Kit has been sold and marketed as infant formula, but product has not submitted to FDA the premarket… Units: 1506 boxes	The Goat Milk Formula Recipe Kit has been sold and marketed as infant formula, but product has not submitted to FDA the premarket notification required for an infant formula for review.	Class I	1506 boxes	FDA report
Apr 18, 2024	Sammy's Milk Sammy's Milk GOAT MILK TODDLER FORMULA, 25.68 oz (78g) pouch; Sammy's Milk GOAT MILK TODDLER FORMULA, 0.64oz (18.2g) Stick Pak FDA inspection and investigation of firm's website and social media pages found that Sammy's online marketing materials included misleading… Units: 1,465 units of 25.68 oz Pouches; 2,487 units of 0.64oz…	FDA inspection and investigation of firm's website and social media pages found that Sammy's online marketing materials included misleading information that implied the product was safe for use as a sole source of…	Class I	1,465 units of 25.68 oz Pouches; 2,487 units of 0.64oz…	FDA report
Dec 30, 2023	Enfamil Enfamil Nutramigen Hypoallergenic Infant Formula Powder with Iron cans (12.6 OZ and 19.8 OZ). Product has the potential to be contaminated with Cronobacter sakazakii. Units: 1,396,438 cans	Product has the potential to be contaminated with Cronobacter sakazakii.	Class I	1,396,438 cans	FDA report
Sep 11, 2023	The Little Oak LittleOak Natural Goat Milk Infant Formula (Stage 1); packaged in 800g (1.8lbs) tin cans - six cans per case.; LittleOak Natural Goat Milk Follow On Infant… No pre-market notification and Mixing instructions not in ounces Units: 14,100 cans; 15,600	No pre-market notification and Mixing instructions not in ounces	Class II	14,100 cans; 15,600	FDA report
Jun 16, 2023	PBM Nutritionals Parent's Choice brand Sensitivity Premium Infant Formula, 638g, packaged in plastic tubs; and Tippy Toes brand Sensitivity Premium Infant Formula, 942g… Inadvertent release of rejected product to market Units: N/A	Inadvertent release of rejected product to market	Class III	N/A	FDA report
May 17, 2023	Nutricia North America TYR Anamix Early Years infant formula Net Wt. 14.1 oz (400g) UPC: 749735002186 Product is a powder packed metal cans. 6 cans per case. Infant formula contains undeclared tyrosine Units: 94 cans	Infant formula contains undeclared tyrosine	Class II	94 cans	FDA report
Mar 17, 2023	Gerber Gerber GoodStart SoothePro Infant Formula with Iron. Infant Formula has the potential to be contaminated with Cronobacter spp. Units: 182,888 cans	Infant Formula has the potential to be contaminated with Cronobacter spp.	Class I	182,888 cans	FDA report
Dec 11, 2022	ByHeart By Heart Whole Nutrition Infant Formula, Net Wt. 24 oz. 680 g Infant formula potentially contaminated with Cronobacter sakazakii Units: 28,554 cans	Infant formula potentially contaminated with Cronobacter sakazakii	Class I	28,554 cans	FDA report
Feb 17, 2022	Similac Abbott EleCare Infant Formula Unflavoured 400g can. 6 cans per case. Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the… Units: 6359 cases; 21126 cases; 1511774 cases; 938215 cases…	Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been produced	Class I	6359 cases; 21126 cases; 1511774 cases; 938215 cases…	FDA report
Dec 23, 2021	Moor Herbs Moor Herbs Healthy Beauty Angel Formula packed in 16oz. plastic containers Product is marketed as an infant formula but the required pre-market infant formula notification for this product has not been submitted to… Units: 147 units	Product is marketed as an infant formula but the required pre-market infant formula notification for this product has not been submitted to the FDA.	Class I	147 units	FDA report
Aug 8, 2021	Able Groupe HiPP Dutch Stage 1 Combiotic Infant Milk Formula; HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula; HiPP HA Germany Hypoallergenic Stage… The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Units: 76,000 units total	The required pre-market notifications for these new infant formulas have not been submitted to the FDA.	Class I	76,000 units total	FDA report
Jun 14, 2021	Designed by Nature Designed by Nature Cow's Milk Formula: 12 oz. plastic pouch. Products are deficient in multiple nutrients required for infant formula, and the firms contract manufacturer does not test for… Units: Cows Milk Formula 171.47 kg; Goat Milk Formula 1688.15 kg…	Products are deficient in multiple nutrients required for infant formula, and the firms contract manufacturer does not test for Cronobacter, a pathogen that can be particularly dangerous to infants and is sometimes…	Class I	Cows Milk Formula 171.47 kg; Goat Milk Formula 1688.15 kg…	FDA report
Jun 11, 2020	Similac Similac Pro-Advance Infant Formula with Iron, Milk-Based, Ready to Feed, 32 FL OZ (1 QT) Water filled bottles labeled as Similac Pro-Advance. Units: 111 total cases.	Water filled bottles labeled as Similac Pro-Advance.	Class III	111 total cases.	FDA report
Sep 13, 2019	Abbott Laboratories Abbott Calcilo XD, Low-calcium Vitamin D-Free Infant formula with iron, powder in a 13.2 oz. can, with 6 cans per case. Off color and odor. Compromised can seam due to product (powder) in the seam, this poor seal potentially allowed air into the container. Units: 2,922 cans	Off color and odor. Compromised can seam due to product (powder) in the seam, this poor seal potentially allowed air into the container.	Class II	2,922 cans	FDA report
Jun 20, 2019	Perrigo Parent's Choice Advantage Infant Formula Milk-Based Powder with Iron, 35 oz, 922 g, with UPC: 078742022468 Product may contain metal fragments. Units: 23,388 containers	Product may contain metal fragments.	Class II	23,388 containers	FDA report
Jan 28, 2015	Similac Similac Advance Complete Nutrition Infant Formula with Iron, 1.45lb plastic container. The firm received three consumer calls of product with Chinese labeling. Units: 51,642/1.45lb containers	The firm received three consumer calls of product with Chinese labeling.	Class II	51,642/1.45lb containers	FDA report

This list covers the recalls we found in FDA enforcement reports, as of October 19, 2026. It isn't a safety rating of any product or brand, and a recall can cover only some models or dates, so check the official notice and search with your lot number before you decide anything.

Source: FDA enforcement reports via openFDA (food). Data as of October 19, 2026.

Brands named most often

Recalls per brand in this list. A recall naming two brands counts for each. Brands with 3 or more have their own page.

Similac3 of 21
ByHeart2 of 21
PBM Nutritionals2 of 21
Abbott Laboratories1 of 21
Able Groupe1 of 21
Dairy Manufacturers1 of 21
Designed by Nature1 of 21
Enfamil1 of 21

9 more brands or companies have one recall or more each; they're in the table above.

These are counts of government recall notices, not ratings. A brand that sells more products can have more recalls, and a recall can cover a single model or production run. Check the notice for the model you own.

Where do I look up formula by lot number?

Check FDA for formula
Infant formula is recalled through the FDA. Its recalls page lists company announcements; match the lot number and use-by date printed on the bottom of the can or container.
Search CPSC by product and model number
Nursery products, toys and other consumer products are recalled through the Consumer Product Safety Commission. Search cpsc.gov/Recallsby brand or product, then match the model number and date code on your product's label to the notice. You can report a problem at SaferProducts.gov.
Register what you own
Car seats and durable nursery products such as cribs, high chairs, strollers and play yards come with a registration card, so the maker can reach you if there's a recall. Mail the card or register on the maker's site.

Questions about infant formula recalls

How many infant formula recalls have there been?

FDA enforcement reports list 21 infant formula recalls since 2012, most recently nara organics brand on June 13, 2026. 3 were announced in the 12 months to October 19, 2026. This count covers the recalls we found in FDA's records, so search with your lot number too.

Which brands have the most infant formula recalls?

In this list, Similac (3), ByHeart (2) and PBM Nutritionals (2) have more than one. 17 brands or companies are named in all. A count of recalls doesn't measure how many products a brand sells or how safe its current products are.

How do I check if my formula is recalled?

Check the lot number and use-by date on the bottom of the container against the recall notice. FDA's recalls page lists company announcements, and the formula maker's site lists affected lots.