FDA Drug recall D-1501-2016
buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahme…
- FDA Drug
- Class III
- terminated
- Published 2016-09-21
On 2016-09-21 the FDA classified a Class III recall of buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahme… by Amerisource Health Services, citing failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1501-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-08-04 |
| Published | 2016-09-21 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Amerisource Health Services |
| Distribution | US |
Product
buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories, NDC 68001-264-03
Reason
Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
Identifiers
| code_info | Lot #: MS1509, Exp 12/17 |
|---|
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-1501-2016%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.