FDA Drug recall D-0149-2017
BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd
- FDA Drug
- Class III
- terminated
- Published 2016-11-30
On 2016-11-30 the FDA classified a Class III recall of BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd by Zydus Pharmaceuticals Usa, citing failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0149-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-08-03 |
| Published | 2016-11-30 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Zydus Pharmaceuticals Usa |
| Distribution | US |
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
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
Identifiers
| ndc | 68382-354-06 |
|---|---|
| ndc | 68382-354-16 |
| ndc | 68382-354-05 |
| ndc | 68382-354-10 |
| ndc | 68382-353-06 |
| ndc | 68382-353-16 |
| ndc | 68382-353-05 |
| ndc | 68382-353-10 |
| code_info | Lot #: MR3365, Exp. Feb 17 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0149-2017%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.