Abbott Ready-to-feed liquid products for infants and children - recalled due to potential for spoilage

United States

Abbott is initiating a voluntary recall of certain lots of 2 fluid ounce/59 milliliter bottles of Ready-to-Feed liquid products for infants and children, including the brands 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 products included in the recall were manufactured at our Columbus, Ohio, manufacturing facility. The products included in the recall were distributed primarily to hospitals and to some doctors’ offices, distributors and retailers in the U.S., including Puerto Rico; one lot of products was sent to Barbados, Bermuda, Colombia, the Dominican Republic, Haiti, Jamaica, St. Croix and St. Thomas; and two lots were sent to Canada, Curacao, Panama, and Trinidad and Tobago.

These products are being recalled because a small percentage of bottles (less than 1%) in the recalled lots have bottle caps that may not have sealed completely, which could result in spoilage. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur.

This recall does not include any other liquid or powder formula brands or other nutrition products produced in our Columbus facility or elsewhere within our global nutrition manufacturing network. It also does not include any amino acid-based formulas or metabolic nutrition formulas.

This recall equates to less than one day's worth of the total number of ounces of infant formula fed in the U.S. and is not expected to impact the overall U.S. infant formula supply. Abbott is continuing production of Similac 2 fluid ounce/59 milliliter Ready-to-Feed liquid formula products for hospitals and healthcare providers' offices on a different production line. Similac infant formula will continue to be produced in alternative product sizes and formats for delivery to retail locations, in addition to increased production throughout our global manufacturing network.

- What Parents and Caregivers Should Do
If a product is included in the recall, do not use the product. For all feeding-related questions or questions about your child’s health, contact a healthcare professional.

To identify if your product is included, please visit similacrecall.com to view a list of impacted lot numbers or use the lot number checker on the webpage.

In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Abbott
Brand name: Multiple brand names
Product recalled: Ready-to-feed liquid products for infants and children
Reason of the recall: Potential for spoilage.
FDA Recall date: October 14, 2022

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbott-voluntarily-recalls-certain-lots-2-fl-oz59-ml-bottles-ready-feed-liquid-products-recall-not