Abbott Laboratories: Food Recall

Recall Details

Recall Number

F-0328-2024

Classification

Class II

Product Type

Food

Recalling Firm

Abbott Laboratories

Status

Terminated

Date Initiated

10/31/2023

Location

Columbus, OH, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

226,650 packets (4,533 cartons)

Reason for Recall

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

Product Description

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

Distribution Pattern

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

Other Recalls by Abbott Laboratories

• Class II: Risk 11/13/2025
  Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations.
• Class II: Risk 09/18/2025
  Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.
• Class II: Risk 03/18/2025
  When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
• Class II: Risk 03/18/2025
  When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
• Class II: Risk 03/18/2025
  When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.

View all recalls by Abbott Laboratories →