U.S. Food and Drug Administration

Summary

Company Announcement

Abbott is initiating a proactive, 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.

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.

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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.

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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.

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.

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.

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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.

“We take our responsibility to deliver high-quality products very seriously,” said Joe Manning, executive vice president, nutritional products, Abbott. “We internally identified the issue, are addressing it, and will work with our customers to minimize inconvenience and get them the products they need.”

If you have questions, please contact Abbott’s Consumer Relations hotlines below in the country where you received product:

• U.S.: +1-800-986-8540
• Puerto Rico: +1-787-622-5454
• Barbados: 246-417-0777
• Bermuda: 279-5568
• Canada: 1-855-733-4201
• Colombia: 1-800-518-9379
• Curacao: 737-2222 Ext. 235, 205
• Dominican Republic: +1-849-200-1564
• Haiti: 868-687-0223
• Jamaica: 876-927-7098
• Panama: 800-0410
• St. Croix: 1(340) 690-7222
• St. Thomas: 1(340) 690-7222
• Trinidad & Tobago: 868-687-0223

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