Nostrum Laboratories, Inc.: Drug Recall

Recall #D-0547-2025 · 07/11/2025

Class II: Risk

Recall Details

Recall Number
D-0547-2025
Classification
Class II
Product Type
Drug
Recalling Firm
Nostrum Laboratories, Inc.
Status
Ongoing
Date Initiated
07/11/2025
Location
Bryan, OH, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
60,608 bottles

Reason for Recall

CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

Product Description

Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120.

Distribution Pattern

nationwide within the United States

Other Recalls by Nostrum Laboratories, Inc.

View all recalls by Nostrum Laboratories, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.