FUROSEMIDE Tablets USP — Class III drug recall D-0011-2016
Terminated recall by Boehringer Ingelheim Roxane Inc, reported 2015-10-21, distributed nationwide. CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP w
| Recall number | D-0011-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boehringer Ingelheim Roxane Inc, Columbus, OH, United States |
| Recall initiated | 2015-09-25 |
| Classified | 2015-10-09 |
| Reported by FDA | 2015-10-21 |
| Terminated | 2016-02-19 |
| Distributed | Nationwide (US) |
| Quantity | 11,110 bottles |
| Reason classes | cgmp |
| NDC | 00054-3294, 00054-3294-46, 00054-3294-50, 00054-3298, 00054-3298-63, 00054-4297, 00054-4297-25, 00054-4297-31, 00054-4299, 00054-4299-25, 00054-4299-31, 00054-4301, 00054-4301-25, 00054-4301-29, 00054-8297, 00054-8297-25, 00054-8299, 00054-8299-25, 00054-8301, 00054-8301-25 |
| Lot numbers | 03/17, 559660P, 559661P |
Product
FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4297-31, UPC 3 0054-4297-31 8.
Reason for recall
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
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-0011-2016. 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.