Formula Recall

May 11, 2022

Important Alert for Community Members Who Use Similac®, Alimentum®, or Elecare® Powdered Formula
The U.S. Food and Drug Administration (FDA) is investigating consumer complaints of Cronobacter and Salmonella infections. All cases reportedly consumed powdered infant formula produced from the Abbott Nutrition facility in Sturgis, Michigan. Abbott has issued a voluntary recall of powdered formulas manufactured in Sturgis. Products made in this facility can be found throughout the U.S.

The FDA is advising consumers not to use Similac, Alimentum, or EleCare powdered infant formulas if:
• The first two digits of the code are 22 through 37 and
• The code on the container contains K8, SH, or Z2, and
• The expiration date is 4-1-2022 (APR 2022) or later.

This investigation is related to four illnesses (three for Cronobacter and one for Salmonella) in the following states: Minnesota, Ohio, and Texas. All four cases related to these complaints were hospitalized, and in one case Cronobacter may have contributed to a death.

On 2/28, Abbott announced it was also voluntarily recalling one lot of Similac PM 60/40 (Lot # 27032K80 (can) / Lot # 27032K800 (case))

In a statement published by Abbott, the company shares, “Additionally, as part of Abbott’s quality processes, we conduct routine testing for Cronobacter sakazakii and other pathogens in our manufacturing facilities. During testing in our Sturgis, Michigan, facility, we found evidence of Cronobacter sakazakii in the plant in non-product contact areas. We found no evidence of  Salmonella Newport. This investigation is ongoing….Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. All finished  infant formula powder products are tested for Cronobacter, Salmonella, and other pathogens, and they must test negative before the product is released. Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter. And the retained sample related to the complaint for Salmonella Newport tested negative for Salmonella.  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. No Abbott liquid formulas are included in the recall, nor are powder formulas or nutrition products from other facilities.”

If you or your child are impacted by this recall, please speak to your health care provider about interim alternative options for elemental formula that may be appropriate for you, such as Essential Care, EquaCare, PurAmino and Neocate.

More Information:

Full FDA announcement.

SimilacRecall.com: This website is dedicated to this recall so that parents can get information, determine if the product they have is included in the recall using the lot locator, and learn how to secure a refund or replacement product.

Consumer Relations Hotline:
Abbott has a Consumer Relations hotline (1-800-986-8540) to ensure parents get their questions answered, determine if any of the product they have is included in the recall and get the most up-to-date information.

Pediatrician Videos:
Video on Similac.com from Abbott’s Pediatric Medical Director and Pediatrician, Dr. Karyn Wulf that speaks directly to parents to provide them with more information about what led to the recall. Sharing this with parents is also a helpful way to provide them with the most up-to-date information available.

Video on EleCare.com from Abbott’s Pediatric Medical Director and Pediatrician, Dr. Karyn Wulf, sharing with parents whose babies and/or children who rely on Alimentum or EleCare.

What You Can Do

  • Check to see if the formula you have is affected by the recall, by checking the lot number on the Abbott website.
  • Do not dilute formula, such as by adding water, in attempt to make your existing supply last, nor attempt to make your own formula.
  • Speak to your doctor before making any changes to your diet or before using an alternate formula (see below).

Elemental Formulas Not Affected by the Recall

  • Cambrooke manufacturers EquaCare and Essential Care elemental formulas. They shared with us on March 23 that their  unflavored and vanilla flavors are shipping within 10 business days. For Chocolate, White Chocolate and Citrus are taking a little longer to ship.
  • Neocate’s blog post describes how they are addressing product demand, and they released this update.
  • Puramino can be ordered online has a zipcode locator to assist parents in finding the product locally. It may also be purchased through Amazon, Their customer number is 1-800-BABY-123 to assist parents with questions.

How We are Advocating

APFED is sharing information with patients, caregivers, clinicians and researchers, and to formula manufacturers. We are working collaboratively with research partners and other advocates to capture data related to accessing specialty ingredients and medical foods like formula during supply chain disruptions, and impacts on health and disease management. The outputs from these collaborations will be published and disseminated to help inform future policies and frameworks to facilitate access to medical foods during events such as supply chain disruptions. We’ll continue to keep you posted.

 

Posted Feb. 24. Updated Mar 17, Mar 24, Apr 7, Apr 12, May 11