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Abbott Laboratories
FDA recall F-0328-2024 · Class II · reported 2023-11-15 · Terminated
- Product
- Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.
- Reason
- Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive
- Quantity
- 226,650 packets (4,533 cartons)
- Distribution
- Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia
- Firm location
- OH, United States
- Initiated
- Voluntary: Firm initiated
- First notice
- Recall started
- 2023-10-31
- Terminated
- 2024-09-03
- Code info
- Lot No. 45002IP Product No. 67397 Best By 09/01/24
Source: U.S. Food and Drug Administration, openFDA Food Enforcement database (openFDA Food Enforcement, imported 2026-09). The FDA does not validate openFDA data for completeness or accuracy. This is a record of an enforcement action, not safety advice.