Similac Probiotic Tri-Blend Recalled for Lack of FDA Approval

Agency Publication Date: November 7, 2023

Summary

Abbott Laboratories is voluntarily recalling 226,650 packets (4,533 cartons) of Similac Probiotic Tri-Blend. The product was marketed for use in preterm infants without the required FDA approval or licensing as a new drug or biologic, and it contains an unsafe food additive. No injuries or illnesses have been reported to date, but the product was distributed to hospitals, healthcare facilities, and specialty retailers across 41 states.

Risk

The product is being recalled because it has not undergone the rigorous FDA safety and effectiveness review required for drugs intended for vulnerable populations like preterm infants. Additionally, it contains a substance that has not been approved as a safe food additive.

What You Should Do

This recall affects Similac Probiotic Tri-Blend packaged in 0.017 oz (0.50g) foil packets, with 50 packets per carton and 3 cartons per case.
Check your packaging for Lot No. 45002IP, Product No. 67397, and a Best By date of 09/01/24.
Return the product to the place of purchase for a refund, throw it away, or contact Abbott Laboratories for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Return the product to the place of purchase for a full refund, or contact the manufacturer or supplier for further instructions

Option 2: Dispose of Product

How to: Throw the product away.

Affected Products

Product: Similac Probiotic Tri-Blend (0.017oz)

Variants: Foil packets, 50 packets per carton, 3 cartons per case

Item Code:

67397

Lot Numbers:

45002IP (Best By 09/01/24)

Recall #: F-0328-2024. Quantity: 226,650 packets (4,533 cartons).

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93348

Status: Resolved

Manufacturer: Abbott Laboratories

Sold By: Hospitals; Healthcare facilities; Specialty retailers

Manufactured In: United States

Units Affected: 226,650 packets (4,533 cartons)

Distributed To: 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

Agency Last Updated: November 28, 2023

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.