Sucralfate Tablets recalled over manufacturing violations

Recall date

October 9, 2025

Source

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

Official notice title

Amerisource Health Services LLC recalls Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohi…

Recall number

D-0027-2026

FDA classification

Class II

Brand / firm

Amerisource Health Services LLC

Sold / distributed

Nationwide within the United States

Why it was recalled

CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 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, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]