Furosemide Tablets USP — Class II drug recall D-0437-2017
Terminated recall by Roxane Laboratories, Inc., reported 2017-02-01, distributed nationwide. Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
| Recall number | D-0437-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roxane Laboratories, Inc., Columbus, OH, United States |
| Recall initiated | 2016-12-22 |
| Classified | 2017-01-23 |
| Reported by FDA | 2017-02-01 |
| Terminated | 2017-12-18 |
| Distributed | Nationwide (US) |
| Quantity | 6,493 bottles |
| 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 | 660833A |
| Expiration dates | 2018-08-31 |
Product
Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31.
Reason for recall
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
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-0437-2017. 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.