FDA Drug recall D-1513-2014
buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India
- FDA Drug
- Class III
- terminated
- Published 2014-08-13
On 2014-08-13 the FDA classified a Class III recall of buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India by Wockhardt Usa, citing failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1513-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-07-14 |
| Published | 2014-08-13 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Wockhardt Usa |
| Distribution | US |
Product
buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA, LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, NDC 64679-101-07.
Reason
Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
Identifiers
| code_info | Lot #: DN10635, Exp 01/15; DM13402, DN10247, Exp 11/14; and DM13449, Exp 07/14 |
|---|
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 II · 2015-08-26 · Wockhardt Usa - Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India
FDA Drug · Class II · 2015-08-26 · Wockhardt Usa - Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC: 64679-715-01) and B) 500 Count Bottles (NDC: 64679-71…
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa - Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0964-01) and B) 3 x 3 Tablet Card Cartons (NDC: 6467…
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1513-2014%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.