Formula Recalls: What to Know Right Now

Mother feeding her baby

Updated October 17, 2022 for additional recall of certain lots of Abbott 2 fluid ounce/59 milliliter bottles of Ready-to-Feed liquid products for infants and children.

(Originally published on February 22, 2022 and updated on March 1, 2022 and again on August 16, 2022)

October 17:
Certain lots of the following products have been voluntarily recalled due to bottle caps that may not have sealed completely, which could cause spoilage: Similac® Pro-Total ComfortTM, Similac® 360 Total Care®, Similac 360 Total Care Sensitive, Similac® Special Care® 24, Similac Stage 1, Similac® NeoSure®, Similac Water (Sterilized) and Pedialyte Electrolyte Solution. The recalled products were manufactured at the Abbott facility in Columbus, Ohio. Please see this link for specific details and lot numbers to check.

August 16:
The FDA recently announced a voluntary recall of products prepared at the Lyons Magnus Plant for concerns products could contain Cronobacter sakazakii and Clostridium botulinum (botulism). These products included Ensure Harvest, PediaSure Harvest, some Kate Farms products and some Glucerna products. Please see this link from the FDA for specific details and lot numbers to check.

March 1:
The Food & Drug Administration recently issued a widespread recall of powdered formula brands Similac, Alimentum and EleCare after several infants were hospitalized with bacterial infections, now including two deaths. As of February 28, the CDC announced another illness of Cronobacter sakazakii which resulted in death of the patient. Abbott Nutrition promptly recalled an additional Similac specialty product which that infant had consumed: Similac PM 60/40*. While no related illnesses have been reported at Connecticut Children’s or in the state of Connecticut, our pediatric experts are taking every possible precaution to ensure the safety of all infants.

If you are currently feeding your child powdered formula or any of the newly recalled Lyons Magnus products as their major source of nutrition, we are here to answer questions and ease any concerns you might have. Dr. James “Jim” Moore, a neonatologist with Connecticut Children’s Specialty Group, addresses what the recall means and what to look out for in your child if they have consumed an affected product.

1. The products are being recalled after complaints related to salmonella Newport, or Cronobacter sakazakii.

So far, there have been three cases of cronobacter infections and one for salmonella in the US, according to the Food and Drug Administration (FDA). Experts believe Cronobacter may have contributed to the passing of one infant.

Cronobacter sakazakii is commonly found in the environment and a variety of areas in the home. Abbott Nutrition, the makers of these formulas, produced the recalled products at its plant in Sturgis, Michigan. They are currently working with the FDA on recalling the remaining batch.

Connecticut Children’s clinical staff members have pulled all recalled products and are using alternative products that are unaffected in all newborn areas.

2. It’s easy to find out if your formula has been affected by this recall.

Only certain products are affected—and this recall does not include liquid or “ready to feed.” If you have a powdered Similac, Alimentum or EleCare powered product, look for:

  • *Lot numbers 27032K80 (can) and 27032K800 (case). These are the only lot numbers for Similac PM 60/40 being recalled.
  • A multi-digit number on the bottom of the container starting with the first two digits 22 through 37
  • The code contains K8, SH, or Z2
  • An expiration date of April 1, 2022 or after

Important:
Please note: this list of recalled products is subject to change as more information becomes available. We encourage you to consult the FDA website frequently.

If you find any of the above, please discard the formula. If you’re unsure, please visit the Product Lookup website (similacrecall.com) and type in the code on the bottom of the package, or call 1.800.986.8540 and follow the instructions.

If you get infant formula through WIC, do not discard. take it to the store for a refund and exchange, or call Abbott Nutrition at 1.800.986.8540 to help you. You should be able to obtain a different brand of similar formula, but the FDA advises you to call your local WIC clinic for more guidance. Also see:

3. If you’re a parent whose child has possibly consumed this formula, stay as calm as possible.

While there is nothing more important to you than your baby’s health, we want to emphasize that incidents of serious illness from these formulas are very low. Please don’t panic, especially if your baby is showing no signs of illness.

4. Watch out for any of these symptoms if your child has consumed the recalled products.

Call your pediatrician right away if your baby has:

  • Fever—a 100.4 temperature is considered a fever in infants
  • Poor feeding—if your baby is consuming significantly less milk or solids
  • Excessive crying or low energy—if your baby seems a lot more fussy or a lot less active than usual
  • Other serious symptoms—look out for signs of sepsis or meningitis such as jaundice (yellow tint in skin and whites of eyes), grunting-like breathing or abnormal movements

5. Know how to report an illness or reaction if your baby has consumed a recalled product.

To report an illness or adverse event to the FDA, you can

6. Remember the major do’s and don’ts of infant formula.

This recall brings to light the importance of formula safety.    

  • Don’t dilute infant formula with water—your baby will not get the nutrients they need.
  • Don’t make homemade formula—homemade formulas are not evaluated by the FDA for safety or proper nutrients. This can be dangerous from a sanitary and health standpoint.
  • Do always check the “use by” date of your formula—this is a general practice everyone should follow. You’ll also want to discard any unused formula that has been open for 30 days, regardless of the “use by” date.

7. If you are at all concerned about your child’s health, no matter what, contact your pediatrician.

That’s what they’re there for—day and night! Please also feel free to call Connecticut Children’s dedicated support line at 860.545.9801.

Helpful Resources:

  • The FDA website is a great resource for formula safety information and bottle feeding.
  • This other FDA webpage has specific questions and answers about infant formula—including regulation, ingredients and more.