Sucralfate Recall: American Health Packaging 1 g tablets
Announced 2026-05-27 · FDA
The recall is for Sucralfate Tablets, USP 1 g, distributed by American Health Packaging, due to CGMP deviations after the firm filed for Chapter 11 in September 2024, which means the products may be adulterated. About 26,992 blister packs distributed nationwide are involved. Lot numbers include 1015038 (exp 07/31/2025), 1015898 (exp 09/30/2025), 1016873 (exp 10/31/2025), and 1023398 (exp 07/31/2026).
| Brand | Amerisource Health Services LLC |
|---|---|
| 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] |
| Reason | CGMP Deviations: The recalling firm filed for Chapter 11 in September 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. |
| Severity | moderate |
| Units affected | 225000 |
| Distribution | Nationwide |
| Agency | FDA |
| Recall / campaign no. | 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. |
WHAT YOU SHOULD DO
- Check if you have recalled lots (1015038, 1015898, 1016873, or 1023398) and do not use any affected product.
- Consult your healthcare provider or pharmacist for guidance and possible alternatives.
- Keep the product packaging; contact your pharmacy or the manufacturer for disposal or return instructions.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.