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Recall Observatory FDA recall evidence

Drug product

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]

D-0027-2026

October 09, 2025

Class II

Product summary

Firm
Amerisource Health Services LLC
Event
Event 97794
Status
Ongoing
Classification
Class II
Quantity
27,868 blister packs
Official record key
drug-enforcement:D-0027-2026

Official wording

Reason: 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.

Code information: Lot #: 1017392, Exp. Date 01/31/2026; 1017415, Exp. Date 12/31/2025.

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations