WhichRecall
Class IIReported 2025-08-06

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.

Recalled by Nostrum Laboratories, Inc.

Reason for Recall

CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024

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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 Number
D-0547-2025
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-07-11
Reported
2025-08-06
Distribution
nationwide within the United States
Code Info
All Lots within expiry dates.
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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