FDA recall record

Abbott Laboratories Similac Probiotic Tri-Blend - 0.017oz recall — FDA F-0328-2024

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

Class IIclassification
F-0328-2024official record ID
Nov 15, 2023report date

Recall record at a glance

Official recordF-0328-2024
CategoryFood Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmAbbott Laboratories
Report dateNov 15, 2023
Recall initiation dateOct 31, 2023
Quantity226,650 packets (4,533 cartons)
LocationColumbus, OH, United States

Official product description

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

Why the product was recalled

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

Distribution information

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

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.

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