buPROPion Hydrochloride Extended-Release Tablet — Class III drug recall D-0857-2022
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2022-05-18, distributed nationwide. Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the
| Recall number | D-0857-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2022-04-29 |
| Classified | 2022-05-10 |
| Reported by FDA | 2022-05-18 |
| Terminated | 2023-09-25 |
| Distributed | Nationwide (US) |
| Quantity | 9,804 bottles |
| NDC | 47335-0736, 47335-0736-08, 47335-0736-13, 47335-0736-86, 47335-0736-88, 47335-0737, 47335-0737-08, 47335-0737-13, 47335-0737-86, 47335-0737-88, 47335-0738, 47335-0738-08, 47335-0738-13, 47335-0738-86, 47335-0738-88 |
| Expiration dates | 2022-10 |
Product
buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in a) 60-count bottle (47335-737-86), b)100-count bottle (47335-737-88), c)500-count bottle (47335-737-13), 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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0857-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.