FDA Drug recall D-0222-2024
buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma Holdings, Inc
- FDA Drug
- Class II
- ongoing
- Published 2024-01-17
On 2024-01-17 the FDA classified a Class II recall of buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma Holdings, Inc by Rising Pharma Holding, citing presence of Foreign Tablets/Capsules.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0222-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-29 |
| Published | 2024-01-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Rising Pharma Holding |
| Distribution | US |
Product
buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, INDIA, NDC 16571-862-03
Reason
Presence of Foreign Tablets/Capsules
Identifiers
| ndc | 16571-862-03 |
|---|---|
| ndc | 16571-862-09 |
| ndc | 16571-862-50 |
| ndc | 16571-862-10 |
| ndc | 16571-862-12 |
| ndc | 16571-863-03 |
| ndc | 16571-863-09 |
| ndc | 16571-863-50 |
| ndc | 16571-863-10 |
| code_info | Lot #: BPA123098A, Exp. Date 06/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0222-2024%22
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