FDA Drug recall D-0280-2019
Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0…
- FDA Drug
- Class II
- terminated
- Published 2018-10-31
On 2018-10-31 the FDA classified a Class II recall of Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0… by Upsher Smith Laboratories, citing failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0280-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-19 |
| Published | 2018-10-31 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Upsher Smith Laboratories |
| Distribution | US |
Product
Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11
Reason
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Identifiers
| ndc | 0832-0540-11 |
|---|---|
| ndc | 0832-0541-11 |
| ndc | 0832-0541-10 |
| ndc | 0832-0542-11 |
| ndc | 0832-0542-10 |
| code_info | Lot#: 375716, Exp 4/30/2020; 372957, 372958, 372959, Exp 3/31/2020; 374541, 375717, 376688, Exp 5/31/2020 |
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-0280-2019%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.