F-0328-2024Class II

Abbott Laboratories

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

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

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. 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. Open the enforcement explorer →