Drug Safety Alerts

Abbott Ready-to-Feed Liquid Products Voluntary Recall

10/14/2022

On October 14, 2022, Abbott issued a voluntary recall 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® NeoSure® and Pedialyte Electrolyte Solution. The products included in the recall were manufactured at Abbott’s Columbus, Ohio, manufacturing facility. This recall was issued 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 may represent a potential health hazard or safety risk to plan members who may be using product affected by this recall.

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

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.

Consumers can visit similacrecall.com to use the lot number checker on the webpage or call Abbott Consumer Relations toll-free 1-800-986-8540 to determine if they have affected product.

Abbott recommends that consumers should not continue using product that is included in this recall.

CVS Caremark Response:

Please note: These products are not carried by the CVS Caremark Mail Service Pharmacies.

If you have questions regarding this recall, please call Abbott Consumer Relations toll-free 1‑800-986-8540, Monday through Friday, 8:30 AM to 5:00 pm (ET) or visit https://www.similacrecall.com.

You may also call the United States Food and Drug Administration (FDA) toll-free at 1‑888 INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.