Class IITerminated in FDA datasetRecall initiated Oct 31, 2023

Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per…

Recalling firm: Abbott Laboratories

Why it was recalled

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

Historical recall record. This is not a new recall announcement. “Terminated” describes the FDA recall process; it does not certify that an individual package is safe. FDA termination date: Sep 3, 2024.

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ProductSimilac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.
Package size0.017oz

FDA code information

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

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Full FDA record and distribution details

Original product description

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

Extracted codes and context

TypeCode / valueContext
best by09/01/24Lot No. 45002IP Product No. 67397 Best By 09/01/24

Original FDA recall reason

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

Recall details

Recall number
F-0328-2024
Event ID
93348
FDA status
Terminated
Initiated
Oct 31, 2023
Reported
Nov 15, 2023
Classified
Nov 7, 2023
Terminated
Sep 3, 2024
Quantity
226,650 packets (4,533 cartons)
Location
Columbus, OH, United States
Initiation type
Voluntary: Firm initiated
Notification
E-Mail

Where it was distributed

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

FDA source record · F-0328-2024

Data updated September 16, 2026. View official FDA data ↗

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