Carbamazepine — Class II drug recall D-1821-2019
Terminated recall by American Health Packaging, reported 2019-08-21, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-1821-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Health Packaging, Columbus, OH, United States |
| Recall initiated | 2019-08-09 |
| Classified | 2019-08-15 |
| Reported by FDA | 2019-08-21 |
| Terminated | 2020-11-06 |
| Distributed | Nationwide (US) |
| Quantity | 457 cartons |
| Reason classes | specification failure |
| NDC | 68084-0562-11, 68084-0562-21 |
| Lot numbers | 181677 |
| Expiration dates | 2020-11-30 |
Product
Carbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister cards x 10 unit doses), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-562-21; NDC Unit Dose: 68084-562-11
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-1821-2019. 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.