Prescription drug recall: Sucralfate tablets due to manufacturing quality concerns
Amerisource Health Services is recalling 27,868 blister packs of Sucralfate tablets nationwide. The firm cannot assure product quality due to Chapter 11 bankruptcy proceedings.
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: This is an FDA Class II prescription drug recall. Although no illnesses or injuries have been reported, the recalling firm cannot assure product quality and purity due to Chapter 11 bankruptcy and inability to monitor its quality assurance program, creating a theoretical risk of adulteration.
Plain-English summary
Amerisource Health Services LLC, doing business as American Health Packaging, is recalling 27,868 blister packs of Sucralfate Tablets, USP 1 gram (Rx Only) distributed nationwide. The affected products are identified by Lot 1017392 (expiration 01/31/2026) and Lot 1017415 (expiration 12/31/2025).
The recalling firm filed for Chapter 11 bankruptcy on September 30, 2024. As a result, it cannot adequately monitor its quality assurance program and cannot ensure that the products meet their identity, strength, quality, and purity specifications as represented.
Patients who have received these tablets should consult their physician or pharmacist regarding alternative treatment options and should not use the recalled tablets.
The recalled product
- Product
- SUCRALFATE (SUCRALFATE)
- Brand
- SUCRALFATE
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug
- Hazard
- product-adulteration
- manufacturing-controls
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 (4)
- Lot #: 1017392
- Exp. Date 01/31/2026
- 1017415
- Exp. Date 12/31/2025.
Distribution
Distributed nationwide across the United States.
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