Abbott Laboratories

Recall #F-0328-2024 · Initiated 2023-10-31

Plain-language summary

by FoodRecallsDB.info

What happened

Abbott Laboratories is recalling Similac Probiotic Tri-Blend packets because the product was marketed for preterm infants without proper FDA approval and contains an unapproved food additive. The recall affects about 226,650 packets distributed across most U.S. states.

Who is at risk

Parents and caregivers who have this specific product and are using it for preterm infants should be concerned.

What to do

Stop using this product if you have it and consult your pediatrician or healthcare provider about safe feeding options for your preterm infant. Check your product packaging to see if it matches the recalled Similac Probiotic Tri-Blend 0.50g foil packets, and contact Abbott or your retailer if you need to return it.

Product

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

Reason for recall

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

Quantity affected

226,650 packets (4,533 cartons)

Distribution

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

Lot / code info

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

Voluntary / mandated

Voluntary: Firm initiated

Initial notification

E-Mail

Terminated

2024-09-03