FDA Drug recall D-0137-2017
Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-2…
- FDA Drug
- Class III
- terminated
- Published 2016-11-23
On 2016-11-23 the FDA classified a Class III recall of Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-2… by Amerisource Health Services, citing failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0137-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-10-27 |
| Published | 2016-11-23 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Amerisource Health Services |
| Distribution | US |
Product
Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-264-03) , Rx only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India For BluePoint Laboratories
Reason
Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
Identifiers
| code_info | Lot #: a) M601509, Exp 3/31/2018; M606506, Exp 4/30/2018; b) M601510, Exp 3/31/2018; M604444, Exp 4/30/2018; M606515, Exp 4/30/2018. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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All Amerisource Health Services recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0137-2017%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.