Carbamazepine Tablets USP — Class III drug recall D-0049-2015
Terminated recall by Taro Pharmaceuticals U.S.A., Inc., reported 2014-11-05, distributed in IL, LA, OH. Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made
| Recall number | D-0049-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY, United States |
| Recall initiated | 2014-10-21 |
| Classified | 2014-10-27 |
| Reported by FDA | 2014-11-05 |
| Terminated | 2017-04-03 |
| Distributed | IL, LA, OH |
| Quantity | 1,966 bottles |
| Reason classes | unapproved product |
| NDC | 51672-4005-03 |
| Lot numbers | 137393 |
| Expiration dates | 2016-10 |
Product
Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 26110 Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4005-3.
Reason for recall
Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. An alternate manufacturing site for the Carbamazepine API final intermediate was pending approval.
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-0049-2015. 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.