Sucralfate tablets recalled after bankruptcy left quality program unmonitored
Sucralfate Tablets USP 1 gram from American Health Packaging are recalled because the firm's Chapter 11 filing left it unable to monitor its quality program. 26,992 blister packs are affected.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; the firm cannot assure the identity, strength, quality or purity of the medicine and no injuries are reported.
Plain-English summary
Sucralfate Tablets, USP 1 gram, in 100-tablet (10x10) unit dose packs and available on prescription only, distributed by American Health Packaging of Columbus, Ohio, carton NDC 60687-695-01 and unit dose NDC 60687-695-11, are being recalled. Affected lots include 1015038 expiring 07/31/2025, 1015898 expiring 09/30/2025 and 1016873 expiring 10/31/2025, with the full list in the recall notice. The recall covers 26,992 blister packs distributed nationwide.
The recall follows current good manufacturing practice deviations. The recalling firm filed for Chapter 11 in September 2024 and as a result cannot monitor its quality program, so it cannot assure that products meet the identity, strength, quality and purity characteristics they are represented to possess, rendering the products adulterated. The FDA classified the action as Class II.
Patients should check the lot number on their carton against the recall and should speak to their pharmacist or prescriber about a replacement supply before stopping a prescribed medicine.
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
- 26,992
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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