Prescription Sucralfate Tablets Recalled Due to Quality Assurance Failure
Amerisource Health Services LLC is recalling Sucralfate tablets nationwide because the company filed for bankruptcy and cannot ensure products meet quality standards.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with inability to assure product quality due to CGMP deviations. No illnesses or injuries have been reported, making this a theoretical hazard of potential adulteration rather than confirmed harm.
Plain-English summary
Amerisource Health Services LLC is recalling Sucralfate (generic name sucralfate) 1-gram tablets distributed nationwide under the brand name SUCRALFATE. The recall affects blister packs from lot numbers 1015038, 1015898, 1016873, and 1023398, with expiration dates ranging from July 2025 to July 2026.
The company filed for Chapter 11 bankruptcy in September 2024. As a result, it cannot monitor and maintain its quality program, preventing it from assuring that products meet the required identity, strength, quality, and purity standards. This renders the products potentially adulterated.
Patients taking this medication should consult their healthcare provider or pharmacist for guidance. The recalled products should not be used and should be returned to a pharmacy or disposed of according to local medication disposal guidelines.
The recalled product
- Product
- SUCRALFATE (SUCRALFATE)
- Brand
- SUCRALFATE
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug
- Hazard
- adulteration
- cgmp-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot 1015038
- Exp Date 07/31/2025
- Lot 1015898
- Exp Date 09/30/2025
- Lot 1016873
- Exp Date 10/31/2025 and Lot 1023398
- Exp Date 07/31/2026.
Distribution
Distributed nationwide across the United States.
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