Home / Recalls / Abbott Laboratories / F-0328-2024

F-0328-2024 Class II Terminated

Recalled by Abbott Laboratories — Columbus, OH

FDA food recall F-0328-2024 was initiated by Abbott Laboratories on October 31, 2023 and is designated Class II. Reason for recall: Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive The recall status is terminated (terminated September 3, 2024). Affected quantity: 226,650 packets (4,533 cartons).

Recall Details

Product Type
Food
Report Date
November 15, 2023
Initiation Date
October 31, 2023
Termination Date
September 3, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
226,650 packets (4,533 cartons)

Product Description

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

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

Code Information

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

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  • Z-1652-2025 Class II — Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08 (March 18, 2025)
  • Z-1655-2025 Class II — Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08 (March 18, 2025)
  • Z-1654-2025 Class II — Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08 (March 18, 2025)
  • Z-1656-2025 Class II — Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04 (March 18, 2025)
  • Z-1653-2025 Class II — Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08 (March 18, 2025)
  • Z-2681-2024 Class II — Alinity hq Analyzer, REF: 09P68-01 (June 14, 2024)
  • Z-1476-2024 Class II — ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. (February 21, 2024)
  • Z-0682-2024 Class II — ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 (October 19, 2023)

FDA data resources