FDA Drug recall D-0049-2015
Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd
- FDA Drug
- Class III
- terminated
- Published 2014-11-05
On 2014-11-05 the FDA classified a Class III recall of Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd by Taro Pharmaceuticals U, citing 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 man….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0049-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-10-21 |
| Published | 2014-11-05 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Taro Pharmaceuticals U |
| Distribution | IL, LA, OH |
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
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.
Identifiers
| ndc | 51672-4041-1 |
|---|---|
| ndc | 51672-4041-2 |
| ndc | 51672-4041-9 |
| ndc | 51672-4041-0 |
| ndc | 51672-4050-1 |
| ndc | 51672-4005-1 |
| ndc | 51672-4005-2 |
| ndc | 51672-4005-3 |
| ndc | 51672-4123-6 |
| ndc | 51672-4123-1 |
| ndc | 51672-4123-3 |
| ndc | 51672-4124-6 |
| ndc | 51672-4124-1 |
| ndc | 51672-4124-3 |
| ndc | 51672-4125-6 |
| ndc | 51672-4125-1 |
| ndc | 51672-4125-3 |
| ndc | 51672-4047-9 |
| ndc | 51672-4047-4 |
| code_info | Lot 137393, exp. 10/2016 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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FDA Drug · Class III · 2022-04-06 · Taro Pharmaceuticals U - Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dis…
FDA Drug · Class I · 2022-01-19 · Taro Pharmaceuticals U - Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd
FDA Drug · Class II · 2021-02-10 · Taro Pharmaceuticals U - Kaiser Permanente Clotrimazole Cream USP, 1% Antifungal Cream, NET WT 1 oz (28.4 g), Manufactured by Taro Pharmaceuticals Inc
FDA Drug · Class II · 2020-12-23 · Taro Pharmaceuticals U
All Taro Pharmaceuticals U recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0049-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.