FDA Recall D-0027-2026

Amerisource Health Services LLC · Columbus, OH

Class II Ongoing 217 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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]

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

Quantity: 27,868 blister packs

Reason for recall

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.

Recall record

Recall number: D-0027-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States
Recall initiated: 2025-10-09
Classified by FDA Center: 2025-10-16
FDA published: 2025-10-22
Recalling firm: Amerisource Health Services LLC
Firm location: Columbus, OH

Drug identification

Brand name(s): SUCRALFATE
Generic name(s): SUCRALFATE
Manufacturer(s): American Health Packaging
NDC(s): 60687-695
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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