← FDA ENFORCEMENT
F-0328-2024Class II

Abbott Laboratories

Recalling firm
Abbott Laboratories
Product type
Food / supplement / cosmetic
Status
Terminated
Report date
2023-11-15
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 state
OH
Product quantity
226,650 packets (4,533 cartons)
Initiated by
Voluntary: Firm initiated
Reason for recall

Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive

Product description

Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.

Code / lot info

Lot No. 45002IP Product No. 67397 Best By 09/01/24

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.