Bumetanide Tablets — Class II drug recall D-0280-2019
Terminated recall by Upsher Smith Laboratories, Inc., reported 2018-10-31, distributed nationwide. Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation
| Recall number | D-0280-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Upsher Smith Laboratories, Inc., Maple Grove, MN, United States |
| Recall initiated | 2018-09-19 |
| Classified | 2018-11-21 |
| Reported by FDA | 2018-10-31 |
| Terminated | 2020-09-30 |
| Distributed | Nationwide (US) |
| Quantity | 44,764 bottles |
| Reason classes | specification failure |
| NDC | 00832-0540, 00832-0540-11, 00832-0541, 00832-0541-10, 00832-0541-11, 00832-0542, 00832-0542-10, 00832-0542-11 |
| Lot numbers | 372957, 372958, 372959, 374541, 375716, 375717, 376688 |
| Expiration dates | 2020-03-31, 2020-04-30, 2020-05-31 |
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 for recall
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
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-0280-2019. 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.