Skip to content
Recall Observatory FDA recall evidence

Drug 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.

D-0547-2025

July 11, 2025

Class II

Product summary

Firm
Nostrum Laboratories, Inc.
Event
Event 97053
Status
Ongoing
Classification
Class II
Quantity
60,608 bottles
Official record key
drug-enforcement:D-0547-2025

Official wording

Reason: 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.

Code information: All Lots within expiry dates.

Distribution pattern: nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations