Sucralfate Tablets recalled over manufacturing violations

Recall date

July 11, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Nostrum Laboratories, Inc. recalls Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033…

Recall number

D-0547-2025

FDA classification

Class II

Brand / firm

Nostrum Laboratories, Inc.

Sold / distributed

nationwide within the United States

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.