American Health Packaging recalled 27,868 blister packs of Sucralfate Tablets on October 9, 2025. The company filed for Chapter 11 bankruptcy, impairing its ability to monitor product quality. Consumers should stop using the product immediately and seek guidance from healthcare providers.
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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The recall involves Sucralfate Tablets, USP 1 gram, packaged in blister packs of 100. The affected lot numbers are 1017392 and 1017415, with expiration dates of January 31, 2026, and December 31, 2025, respectively. These products were distributed nationwide within the United States.
The recall stems from Current Good Manufacturing Practice (CGMP) deviations. The company cannot assure that the products meet the required identity, strength, quality, and purity characteristics, rendering them adulterated.
No specific incidents or injuries have been reported related to this recall. The potential risks associated with the adulterated product necessitate immediate action.
Consumers should stop using the recalled Sucralfate Tablets immediately. Contact Amerisource Health Services LLC or a healthcare provider for further guidance and to discuss the return process.
For more information, contact Amerisource Health Services LLC at 1-800-XXX-XXXX or visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0027-2026.
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