Recalls / Class II

Class IID-0547-2025

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.

Affected lot / code info

All Lots within expiry dates.

Why it was recalled

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.

Recalling firm

Firm

Nostrum Laboratories, Inc.

Notification channel

Press Release

Type

Voluntary: Firm initiated

Address

705 E Mulberry St, Bryan, Ohio 43506-1432

Distribution

Quantity

60,608 bottles

Distribution pattern

nationwide within the United States

Timeline

Recall initiated

2025-07-11

FDA classified

2025-07-31

Posted by FDA

2025-08-06

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0547-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.