BuPROPion Hydrochloride Extended-Release Tablets — Class III drug recall D-0207-2017
Terminated recall by Zydus Pharmaceuticals USA Inc, reported 2016-12-28, distributed nationwide. Failed Dissolution Specifications; 6 month time point
| Recall number | D-0207-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals USA Inc, Pennington, NJ, United States |
| Recall initiated | 2016-11-02 |
| Classified | 2016-12-20 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2020-07-23 |
| Distributed | Nationwide (US) |
| Quantity | 16,356 bottles |
| Reason classes | specification failure |
| NDC | 68382-0353, 68382-0353-05, 68382-0353-06, 68382-0353-10, 68382-0353-16, 68382-0354, 68382-0354-05, 68382-0354-06, 68382-0354-10, 68382-0354-16 |
| Expiration dates | 2018-01, 2018-03, 2018-04, 2018-06 |
Product
BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534
Reason for recall
Failed Dissolution Specifications; 6 month time point
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-0207-2017. 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.