Agency classClass IIOur severity:High FDA (Food)·F-0328-2024·Announced 2023-11-15

Infant Probiotic Supplement Recall: Abbott Similac Tri-Blend Unsafe Additive

Abbott Laboratories has recalled Similac Probiotic Tri-Blend infant supplement packets due to regulatory violations: the product was marketed without FDA approval as a new drug and contains an unsafe food additive.

The agency’s classification

FDA (Food): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Per FDA severity criteria, this is a Class II recall involving a risk-of-harm product—an unsafe food additive marketed to vulnerable preterm infants without drug approval. No illnesses or injuries have been reported, placing this at High severity for products with risk but without documented injury.

Plain-English summary

Abbott Laboratories is recalling Similac Probiotic Tri-Blend, a probiotic supplement for preterm infants. The product consists of 0.017 oz (0.50 g) packets, supplied 50 per carton. The recall encompasses 226,650 packets (4,533 cartons) bearing Lot No. 45002IP, Product No. 67397, with a Best By date of 09/01/24.

The FDA has determined that this product was marketed toward preterm infants without approval as a new drug or licensed biologic. Additionally, the product contains an unsafe food additive. These regulatory and safety violations present potential risks, particularly to the vulnerable preterm infant population.

The recalled product was distributed across the United States, including 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, and West Virginia.

Consumers should not use this product. If you have purchased it, do not give it to your infant. Contact your pediatrician if your child has consumed this product.

The recalled product

Product: Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.
Manufacturer: Abbott Laboratories
Category: Food — Infant Supplement
Hazard: unapproved-drug-marketing
unsafe-additive

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed in 41 states:

Same manufacturer · Abbott Laboratories

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Same hazard · unapproved drug marketing