The Recall Desk
HighFDA (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.

What this means for you

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

Distribution scope not specified by the agency.

Related recalls

Same category