American Health Packaging recalled 26,992 blister packs of Sucralfate Tablets on July 29, 2025. The recall follows CGMP deviations that affect product quality. Consumers should stop using the product immediately and seek guidance from healthcare providers.
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.
Consumers and healthcare providers should stop using this product immediately. Contact Amerisource Health Services LLC or your healthcare provider for guidance. Notification method: Letter
The recall involves Sucralfate Tablets, USP 1 gram, packaged in blister packs of 100 tablets. The affected lot numbers are 1015038, 1015898, 1016873, and 1023398, with expiration dates extending to July 31, 2026.
The recall results from the firm's inability to assure the identity, strength, quality, and purity of the products. CGMP deviations render the items adulterated, posing potential health risks to consumers.
No specific incidents or injuries related to this recall have been reported as of the announcement date.
Consumers and healthcare providers should stop using Sucralfate Tablets immediately. Contact Amerisource Health Services LLC for further instructions.
For inquiries, consumers can reach Amerisource Health Services LLC. More information is available at the FDA recall page.
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