FDA Recall D-0547-2025

Nostrum Laboratories, Inc. · Bryan, OH

Class II Ongoing 307 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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.

Lot / code: All Lots within expiry dates.

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.

Recall record

Recall number: D-0547-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: nationwide within the United States
Recall initiated: 2025-07-11
Classified by FDA Center: 2025-07-31
FDA published: 2025-08-06
Recalling firm: Nostrum Laboratories, Inc.
Firm location: Bryan, OH

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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