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Infant formula recall tracker

Which infant formulas are under recall right now. Read live from the FDA’s enforcement database and merged with our own record of recalls outside the United States, which never enter the FDA system at all.

FDA data last updated 2026-08-12. This page refreshed 2026-08-23. It updates itself; nobody edits it by hand.

2 formulas under active recall

Do not feed these products. Class I is the FDA’s most serious category: a reasonable probability of serious adverse health consequences or death. Check the official notice rather than the tin, because recalls are usually scoped to specific lot codes.

  • Class INARA ORGANICS INC

    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 organics brand; Whole Milk Organic Infant Formula; Milk-based Powder with Iron; 0-12 months; NET WT 14.1 OZ (400 G); UPC: 860013251918

    Product may be contaminated with Clostridium botulinum.

    Distribution:
    nationwide
    Quantity:
    377,610 cans
    Source:
    FDA enforcement report, Ongoing
  • Class IByHeart

    ByHeart Whole Nutrition

    Clostridium botulinum Type A contamination traced to organic whole milk powder, multistate infant botulism outbreak. CDC closed the investigation in February 2026 with a final count of 48 infant cases (28 confirmed, 20 probable) across 17 states, all hospitalized, no deaths.

    Source:
    Atlas record
    Official notice

How “active” is decided here

This matters, because the obvious rule gives the wrong answer. The FDA marks an enforcement report Ongoing until it is formally terminated, which is a paperwork state rather than a statement about danger. Right now 25 infant-formula reports are open, and 23 of them are from events that closed years ago — most of them the Abbott Sturgis records from February 2022, an episode that ended with the plant rebuilt and production restarted.

So this page shows a recall as active only when it is Class I, its FDA report is still open, and it was initiated within the last 18 months. That window is our judgement, not the FDA’s, which is why it is written here rather than buried. Nothing is hidden: the older open reports are counted above and the closed ones are listed below.

Open enforcement reports from older events (23)

The FDA has not formally terminated these, but they are not current warnings. They are here so the count above can be checked rather than taken on trust.

  • Class IIValley Springs Artesian Gold, LLC

    Valley Springs 100% Natural Bottled Water packaged in the following size plastic jug with plastic caps: 1. 1 Gal Net 128 Fl oz. UPC 0 31193-00701 9. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. 2. 2.5 Gallon Net (320 Fl oz./9.4L). UPC 0 31193-01501 4. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. 3. Infant Water, 1 Gal Net, 128 FL. Oz. Not sterile. Use as directed by physician or by labeling directions for use of infant formula. UPC 0 31193-01401 7. 4. Daisy's Doggy Water, 1 Gal Net, 128 FL. Oz. 100% Pure Water. No Chlorine. UPC 0 31193-90100 3. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. Distributed by DDW LLC, 109 S. Thompson Rd., Sun Prairie, WI 53590.

    Water was bottled under insanitary conditions.

    Distribution:
    IL, WI
    Quantity:
    379,868 units
    Source:
    FDA enforcement report, Ongoing
  • Class IAbbott Laboratories

    Abbott Similac Advance Infant Formula with Iron 12.4oz. can, 23.2oz. plastic jar, 20.6oz. plastic jar. 6 units per case. Abbott Similac Pro-Advance 34oz. plastic jar. 6 jars per case. Item numbers: 53359 68084 5595776 6748701 Retail UPCs: 070074533605 070074680859 070074559582 070074122373

    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

    Distribution:
    US Nationwide. Worldwide.
    Quantity:
    3491684 cases
    Source:
    FDA enforcement report, Ongoing
  • Class IAbbott Laboratories

    Abbott Similac For Spit Up Infant Formula with Iron 22.5oz plastic jar. 6 jars per case. Item numbers: 5372976 Retail UPCs: 070074537306

    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

    Distribution:
    US Nationwide. Worldwide.
    Quantity:
    21126 cases
    Source:
    FDA enforcement report, Ongoing
  • Class IAbbott Laboratories

    Abbott Similac For Spit Up Infant Formula with Iron 7oz. can and 19.5oz. plastic jar. 6 units per case. Item numbers: 67927 68086 Retail UPCs: 070074679280 070074680873

    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

    Distribution:
    US Nationwide. Worldwide.
    Quantity:
    138075 cases
    Source:
    FDA enforcement report, Ongoing
  • Class IAbbott Laboratories

    Abbott Similac Organic 7oz. can. 6 cans per case. Abbott Similac Organic with A2 Milk Infant Formula with Iron 20.6oz. plastic jar. 4 jars per case. 23.2oz plastic jar. 6 jars per case. Item numbers: 68013 68092 5082178 Retail UPCs: 070074680156 070074680934 070074508221

    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

    Distribution:
    US Nationwide. Worldwide.
    Quantity:
    52663 cases
    Source:
    FDA enforcement report, Ongoing
  • Class IAbbott Laboratories

    Abbott Similac Sensitive Infant Formula with Iron 22.5oz. plastic jar. 6 jars per case. Item numbers: 5081776 Retail UPCs: 070074508184

    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

    Distribution:
    US Nationwide. Worldwide.
    Quantity:
    46757 cases
    Source:
    FDA enforcement report, Ongoing
  • Class IAbbott Laboratories

    Abbott Similac Sensitive 34oz. plastic jar. 6 jars per case. Abbott Similac Sensitive Infant Formula with Iron 12.5oz. can and 20.1oz. plastic jar. 6 units per case. Item numbers: 68082 5753978 6748901 674891L Retail UPCs: 070074680835 070074575414 070074122380

    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

    Distribution:
    US Nationwide. Worldwide.
    Quantity:
    2046814 cases
    Source:
    FDA enforcement report, Ongoing
  • Class IAbbott Laboratories

    Abbott Similac 360 Total Care Sensitive Infant Formula with Iron 7oz. can. 6 cans per case. 20.1oz. and 29.5oz. plastic jar. 4 jars per case. Item numbers: 68070 68072 68118 Retail UPCs: 070074680712 070074680736 070074681191

    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

    Distribution:
    US Nationwide. Worldwide.
    Quantity:
    227970 cases
    Source:
    FDA enforcement report, Ongoing
  • Class IAbbott Laboratories

    Abbott Similac Alimentum Allergies & Colic Hypoallergenic Infant Formula 400g. can. 6 cans per case. Item numbers: 5707713 Retail UPCs: 055325000624

    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

    Distribution:
    US Nationwide. Worldwide.
    Quantity:
    45223 cases
    Source:
    FDA enforcement report, Ongoing
  • Class IAbbott Laboratories

    Abbott Similac Organic with A2 Milk Toddler Drink 23.2oz plastic jar. 4 jars per case. Abbott Similac Organic Toddler with A2 Milk Infant Formula with Iron 20.6oz. plastic jar. 4 jars per case. Item numbers: 67905 68104 Retail UPCs: 070074677576 070074681054

    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

    Distribution:
    US Nationwide. Worldwide.
    Quantity:
    8514 cases
    Source:
    FDA enforcement report, Ongoing
  • Class IAbbott Laboratories

    Abbott Similac Total Comfort Infant Formula with Iron 12.6oz. can. 6 cans per case. Item numbers: 62599 Retail UPCs: 070074626000

    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

    Distribution:
    US Nationwide. Worldwide.
    Quantity:
    1226623 cases
    Source:
    FDA enforcement report, Ongoing
  • Class IAbbott Laboratories

    Abbott Similac 360 Total Care Infant Formula with Iron 20.6oz. and 30.3oz. palstic jar. 4 jars per case. 7oz. can. 6 cans per case. Item numbers: 68063 68065 68109 Retail UPCs: 070074680644 070074680668 070074681108

    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

    Distribution:
    US Nationwide. Worldwide.
    Quantity:
    342054 cases
    Source:
    FDA enforcement report, Ongoing

11 further open reports from the same events are not listed individually.

Closed recalls (24)

Terminated by the FDA, or resolved outside the US system. Kept because a family choosing a brand today is entitled to know its history.

  • Voluntarya2 Platinum

    a2 Platinum Stage 1

    Possible cereulide (Bacillus cereus toxin) contamination

    Source:
    Atlas record
    Official notice
  • Class IThe a2 Milk Company

    a2 Platinum Premium infant formula Milk-based Powder with Iron 31.7oz (900g) Intended use: infant formula (0 12 months). Condition: shelf stable product Type of packaging: metal tin with plastic dust cap. Net weight: 31.7oz (900gm). UPC: 813267020335. Firm name listed on label: The a2 Milk Company. 4909 Pearl East Circle, Suite 300 Boulder CO 80301.

    Possible contamination with Cereulide toxin.

    Distribution:
    The recalled product was distributed throughout the United States.
    Quantity:
    51,202 units
    Source:
    FDA enforcement report, Terminated
  • VoluntaryByHeart

    ByHeart Whole Nutrition

    Infant botulism investigation

    Source:
    Atlas record
    Official notice
  • Class IIPBM Nutritionals, LLC

    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 41220164578

    Product contains levels of Vitamin D above the maximum level permitted.

    Distribution:
    TX, FL, CA, SC, VA, IN, TN, NJ, MI, PA, RI, MO
    Quantity:
    16,500 units
    Source:
    FDA enforcement report, Terminated
  • VoluntaryBobbie

    Bobbie Original

    Certain lots did not meet the minimum iron content standard per FDA testing

    Source:
    Atlas record
    Official notice
  • Class IDairy Manufacturers, Inc

    Crecelac Infant 0-12 powdered infant formula with iron 12.4 oz 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 standards. Cronobacter spp. detected by FDA sampling.

    Distribution:
    Throughout Texas
    Quantity:
    5376 cans
    Source:
    FDA enforcement report, Terminated
  • Class IDairy Manufacturers, Inc

    Farmalac powdered infant formula with iron 12.4 oz 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 standards.

    Distribution:
    Throughout Texas
    Quantity:
    5376 cans
    Source:
    FDA enforcement report, Terminated
  • Class IDairy Manufacturers, Inc

    Farmalac 0-12 Low lactose powdered infant formula with iron 12.4 oz 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 standards.

    Distribution:
    Throughout Texas
    Quantity:
    5376 cans
    Source:
    FDA enforcement report, Terminated
  • Class IMead Johnson & Company LLC

    Enfamil Nutramigen Hypoallergenic Infant Formula Powder with Iron cans (12.6 OZ and 19.8 OZ). UPC Code of 300871239418 or 300871239456 and Use By Date of "1 Jan 2025".

    Product has the potential to be contaminated with Cronobacter sakazakii.

    Distribution:
    Retail stores and medical facilities nationwide and outside the U.S.
    Quantity:
    1,396,438 cans
    Source:
    FDA enforcement report, Terminated
  • Class IIThe Little Oak Company Ltd

    LittleOak Natural Goat Milk Follow On Infant Formula (Stage 2); packaged in 800g (1.8lbs) tin cans - six cans per case.

    No pre-market notification and Mixing instructions not in ounces

    Distribution:
    WY, CA, NY, GA, IL, UT, MD, CO, PA, VT, TX, IN, FL, CT, HI, SC, MN, LA, NJ, MI, WA, OH, KY, NM, ID, MO, OK, NV, AR, NE, IA, MA, VA, TN, NC, AK, AV, AL, NH, SD, WI, PR, RI, KS, ME, MT, DC
    Quantity:
    15,600
    Source:
    FDA enforcement report, Terminated
  • Class IIThe Little Oak Company Ltd

    LittleOak Natural Goat Milk Infant Formula (Stage 1); packaged in 800g (1.8lbs) tin cans - six cans per case.

    No pre-market notification and Mixing instructions not in ounces

    Distribution:
    WY, CA, NY, GA, IL, UT, MD, CO, PA, VT, TX, IN, FL, CT, HI, SC, MN, LA, NJ, MI, WA, OH, KY, NM, ID, MO, OK, NV, AR, NE, IA, MA, VA, TN, NC, AK, AV, AL, NH, SD, WI, PR, RI, KS, ME, MT, DC
    Quantity:
    14,100 cans
    Source:
    FDA enforcement report, Terminated
  • Class IIIPBM Nutritionals, LLC

    Parent's Choice brand Sensitivity Premium Infant Formula, 638g, packaged in plastic tubs; and Tippy Toes brand Sensitivity Premium Infant Formula, 942g, packaged in composite cans

    Inadvertent release of rejected product to market

    Distribution:
    IL, AL, IA, GA, MS, IN, AR, CO, FL, VA, OH, WI, PA, NH, AZ, KS, TX, TN, NC, LA, MO, KY, DE, WI
    Quantity:
    N/A
    Source:
    FDA enforcement report, Terminated
  • Class IINutricia 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

    Distribution:
    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.
    Quantity:
    94 cans
    Source:
    FDA enforcement report, Terminated
  • Class IPerrigo Nutritionals

    Gerber GoodStart SoothePro Infant Formula with Iron. Milk Based Powder. Stage 1, 0 - 12 Months. Nestle Infant Nutrition, Arlington, VA 22209. Packaged in the following sizes: 1. Net Wt 12.4 oz. (351 g) (6 cans per case) UPC 050000-62400 3 2. Net Wt 30.6 oz. (1.91 lb / 867 g) (4 cans per case) UPC 0 50000-49498 9 3. Net Wt 19.4 oz. (1.21 lb/549 g) (4 cans per case) UPC 0 50000-48722 6 4. Product only sold in Canada: 942g (4 cans per case) UPC 0 55000-38369 1.

    Infant Formula has the potential to be contaminated with Cronobacter spp.

    Distribution:
    Nationwide and Canada.
    Quantity:
    182,888 cans
    Source:
    FDA enforcement report, Terminated
  • VoluntaryByHeart

    ByHeart Whole Nutrition

    Cronobacter sakazakii concern

    Source:
    Atlas record
    Official notice

What to do if your formula is listed

  1. Stop using it and check the lot code against the official notice. Most recalls cover specific lots rather than every tin of a product.
  2. Do not dilute what you have to make it last, and do not improvise a substitute. See the formula shortage navigator.
  3. Switch to a comparable formula rather than the nearest tin on the shelf. Composition matters more than brand during a switch, and the switching guide covers how to do it without upsetting a baby’s digestion.
  4. If your baby has symptoms, contact your pediatrician. For infant botulism specifically, poor feeding, weak cry, drooping eyelids and constipation are the signs to act on, and they warrant emergency care.

Related reading

Recall data comes from the openFDA Food Enforcement API. The FDA’s own disclaimer applies: the data is provided as-is and should not be relied on for medical decisions. For anything urgent, use the FDA recall page directly.