27,868 blister packs of Sucralfate Tablets, 1 g, distributed nationwide by American Health Packaging are recalled. The recall stems from CGMP deviations that prevent the firm from assuring product identity, strength, quality and purity. Health providers and consumers should stop using the product immediately and await guidance.
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.
Consumers and healthcare providers should stop using this product immediately. Contact Amerisource Health Services LLC or your healthcare provider for guidance. Notification method: Letter
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Sucralfate is used to treat active duodenal and gastric ulcers. The recalled product is an oral tablet issued Rx only and distributed nationwide. This recall centers on CGMP deviations, not on reported patient harm.
CGMP deviations prevent the sponsor from ensuring the product’s identity, strength, quality and purity. The product is deemed adulterated under current manufacturing standards.
This recall is not presented as part of a broader industry pattern.
Patients relying on this therapy could be affected if the product does not meet quality standards. No injuries reported yet, but adulteration risk warrants stopping use and seeking guidance.
Recall letter and FDA enforcement page list affected lots and disposal/return instructions
Refunds or replacements, if offered, will be communicated via recall notification letter; no specific timeline published
Keep the recall notice, take photos of packaging, save purchase receipts, document lot numbers and expiration dates, log any adverse events
Product: Sucralfate Tablets, USP 1 g, 100 tablets, (10x10) Rx Only NDC: 60687-695-01 Carton NDC: 60687-695-11 Distributor: American Health Packaging, Columbus, OH 43217 Quantity recalled: 27,868 blister packs Distribution: Nationwide in the United States Recall date: 2025-10-09 Status: Active Brand: Sucralfate Lot numbers/Exp dates: Lot 1017392 — Exp 01/31/2026; Lot 1017415 — Exp 12/31/2025
No injuries or incidents have been reported.
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