Abbott is initiating a proactive, voluntary recall of certain lots of 2 fl oz/59 ml bottles of ready-to-feed liquid products, including the brands Similac Pro-Total Comfort®, Similac® 360 Total Care®, Similac® 360 Total Care® Sensitive, Similac® Special Care® 24, Similac® Stage 1, Similac® Water (Sterilized), Similac® NeoSure®, and Pedialyte® Electrolyte Solution. These products were manufactured at the company’s Columbus, Ohio, manufacturing facility and distributed primarily to hospitals, doctor’s offices, distributors, and some retailers in the US, including Puerto Rico; a limited number of products were sent to Canada, Colombia, the Dominican Republic, Panama, and certain countries in the Caribbean.
2 fl oz ready-to-feed liquid products included in this voluntary recall:
It’s important to note that not all recalled products were distributed in all countries and not all 2 fl oz/59 ml formulas are included in the recall. It is therefore important to verify the product lot number on the bottom or the side of the bottle. Click on the "Learn More" button to see lot numbers included in the recall or scroll down to Check Lot Number.
We are voluntarily initiating this recall because a small percentage of bottles in the recalled lots have bottle caps that may not have sealed completely, which could result in product spoilage.
02.28.2022 – UPDATE: Abbott is voluntarily recalling one lot of Similac PM 60/40 (Lot # 27032K80 (can) / Lot # 27032K800 (case)) manufactured in Sturgis, Michigan. This is in addition to lots of Similac®, Alimentum® and EleCare® powder formula that were voluntarily recalled on Feb. 17. 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. We want to extend our heartfelt sympathies to the family.
Importantly, no distributed product has tested positive for the presence of Cronobacter sakazakii. Additionally, recently tested retained product samples of Similac PM 60/40 Lot # 27032K80 (can) / Lot #27032K800 (case) were negative for Cronobacter.
02.17.2022 - 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.
Abbott is voluntarily recalling these products after four consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants who had consumed powder infant formula manufactured in this facility.
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.
Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. 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.
If your infant is experiencing symptoms related to Cronobacter or Salmonella infection, such as poor feeding, irritability, temperature changes, jaundice, grunting breaths, abnormal movements, lethargy, rash, or blood in the urine or stool; contact your health care provider to report their symptoms and receive immediate care.
To find out if the product you have is included in this recall, click on the button below to check your lot number.
