Carbamazepine Extended-Release Tablets — Class II drug recall D-0675-2025
Ongoing recall by Amerisource Health Services LLC, reported 2025-10-08, distributed nationwide. Failed Dissolution Specifications.
| Recall number | D-0675-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amerisource Health Services LLC, Columbus, OH, United States |
| Recall initiated | 2025-09-15 |
| Classified | 2025-09-29 |
| Reported by FDA | 2025-10-08 |
| Distributed | Nationwide (US) |
| Quantity | 360 cartons |
| Reason classes | specification failure |
| NDC | 60687-0583, 60687-0583-11, 60687-0583-21, 60687-0594, 60687-0594-11, 60687-0594-21 |
| Lot numbers | 1024078 |
| Expiration dates | 2026-08-31 |
Product
Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11)
Reason for recall
Failed Dissolution Specifications.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0675-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.