FDA Drug recall D-1345-2015
buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed by: Sun Pharmaceutic…
- FDA Drug
- Class III
- terminated
- Published 2015-08-26
On 2015-08-26 the FDA classified a Class III recall of buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed by: Sun Pharmaceutic… by Sun Pharma Global Fze, citing failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meetin….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1345-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-07-17 |
| Published | 2015-08-26 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sun Pharma Global Fze |
| Distribution | US |
Product
buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, Manufactured By: Sun Pharmaceutical Ind. Ltd., Halol Baroda Highway, Halol 389 350, Gujarat, India, NDC 47335-738-86
Reason
Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.
Identifiers
| 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 |
| code_info | Lot #s: JKM4152A, JKM4737A, JKM5270A, Exp 08/2015 |
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-1345-2015%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.