FDA Drug recall D-0007-2017
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only, Distributed by: Sun Pharmace…
- FDA Drug
- Class III
- terminated
- Published 2016-10-12
On 2016-10-12 the FDA classified a Class III recall of buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only, Distributed by: Sun Pharmace… by Sun Pharmaceutical Industries, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0007-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-09-13 |
| Published | 2016-10-12 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
Product
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by Sun Pharmaceuticals Ind. Ltd. Halol- Baroda Highway, Halol-389 350, Gujarat, India. UPC 347335737868 NDC 47335-737-86
Reason
Failed Dissolution Specifications
Identifiers
| upc | 347335737868 |
|---|---|
| ndc | 47335-736-86 |
| ndc | 47335-736-88 |
| ndc | 47335-736-08 |
| ndc | 47335-736-13 |
| ndc | 47335-737-86 |
| ndc | 47335-737-88 |
| ndc | 47335-737-08 |
| ndc | 47335-737-13 |
| ndc | 47335-738-86 |
| ndc | 47335-738-88 |
| ndc | 47335-738-08 |
| ndc | 47335-738-13 |
| ndc | 3473357378 |
| code_info | JKN5124A and JKN5229A, exp 10/2016 |
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-0007-2017%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.