FDA Drug recall D-0858-2022
buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, Rx only Distributed by: Sun Pharmaceutical Industries,…
- FDA Drug
- Class III
- terminated
- Published 2022-05-18
On 2022-05-18 the FDA classified a Class III recall of buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, Rx only Distributed by: Sun Pharmaceutical Industries,… by Sun Pharmaceutical Industries, citing presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0858-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-04-29 |
| Published | 2022-05-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
Product
buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, Rx only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-738-86
Reason
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
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 #: HAC2237A, exp. date 05/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0858-2022%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.