Sucralfate tablets recalled after bankruptcy left quality program unmonitored
Amerisource Health Services is recalling 27,868 blister packs of Sucralfate Tablets USP 1 gram because, after a Chapter 11 filing, the firm cannot monitor its quality program.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 as a precautionary quality-system action: the record cites an inability to assure quality after a bankruptcy filing, without identifying any defect in the product or reporting harm.
Plain-English summary
Sucralfate Tablets, USP 1 gram, in 100-tablet (10x10) blister packs distributed by American Health Packaging of Columbus, Ohio, are being recalled for CGMP deviations.
The recalling firm filed for Chapter 11 on 30 September 2024. As a result it cannot monitor the quality program and so cannot assure that products meet the identity, strength, quality and purity characteristics they are purported or represented to possess, which renders the products adulterated.
The recall covers 27,868 blister packs from lots 1017392 (expiring 31 January 2026) and 1017415 (expiring 31 December 2025), carrying NDC 60687-695-01. The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
The enforcement record identifies no specific defect in the tablets themselves and reports no injuries. Patients holding an affected lot should contact their pharmacy or prescriber about a replacement rather than stopping treatment on their own.
The recalled product
- Product
- Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug — Gastrointestinal
- Affected units
- 27,868
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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