buPROPion HCl Extended-Release Tablets — Class III drug recall D-1513-2014
Terminated recall by Wockhardt Usa Inc., reported 2014-08-13, distributed nationwide. Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were
| Recall number | D-1513-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wockhardt Usa Inc., Parsippany, NJ, United States |
| Recall initiated | 2014-07-14 |
| Classified | 2014-08-05 |
| Reported by FDA | 2014-08-13 |
| Terminated | 2015-01-12 |
| Distributed | Nationwide (US) |
| Quantity | 840 bottles |
| Reason classes | specification failure |
| NDC | 64679-0101-07 |
| Lot numbers | 01/15, 07/14, 11/14, DM13402, DM13449, DN10247, DN10635 |
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 for recall
Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
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-1513-2014. 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.