BuPROPion Hydrochloride Extended-Release Tablets — Class III drug recall D-0149-2017
Terminated recall by Zydus Pharmaceuticals USA Inc, reported 2016-11-30, distributed nationwide. Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time poin
| Recall number | D-0149-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals USA Inc, Pennington, NJ, United States |
| Recall initiated | 2016-08-03 |
| Classified | 2016-11-22 |
| Reported by FDA | 2016-11-30 |
| Terminated | 2018-07-12 |
| Distributed | Nationwide (US) |
| Quantity | 2,472 units |
| 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 |
| Lot numbers | MR3365 |
Product
BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA inc. Pennington, NJ 08534, NDC 68382-354-05
Reason for recall
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate 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-0149-2017. 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.