Carbamazepine Tablets — Class II drug recall D-0770-2026
Ongoing recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2026-08-26, distributed nationwide. CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
| Recall number | D-0770-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2026-08-03 |
| Classified | 2026-08-18 |
| Reported by FDA | 2026-08-26 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp |
| NDC | 51672-4005-03 |
| Lot numbers | AD94033 |
| Expiration dates | 2028-05-31 |
Product
Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3.
Reason for recall
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
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-0770-2026. 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.