FDA Drug recall D-1446-2016
buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical Industries, Inc
- FDA Drug
- Class III
- terminated
- Published 2016-07-27
On 2016-07-27 the FDA classified a Class III recall of buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical Industries, Inc by Sun Pharmaceutical Industries, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1446-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-06-27 |
| Published | 2016-07-27 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
Product
buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol 389-350 Gujarat India ---- NDC 47335-737-86
Reason
Failed Dissolution 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 JKN3477A, exp 07/2016 |
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-1446-2016%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.