FDA Drug recall D-0590-2024
buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: Am…
- FDA Drug
- Class II
- ongoing
- Published 2024-07-17
On 2024-07-17 the FDA classified a Class II recall of buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: Am… by Amerisource Health Services, citing failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0590-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-24 |
| Published | 2024-07-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amerisource Health Services |
| Distribution | US |
Product
buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 60687-782-01.
Reason
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Identifiers
| ndc | 60687-782-11 |
|---|---|
| ndc | 60687-782-01 |
| ndc | 60687-793-11 |
| ndc | 60687-793-21 |
| code_info | Lot 1017343, Exp. 12/31/2025 |
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-0590-2024%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.