FDA Recall Furosemide

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Furosemide with NDC 0054-8301 was initiated on 12-22-2016 as a Class II recall due to failed tablet/capsule specifications: an unusually thick tablet was reported through a complaint. The latest recall number for this product is D-0437-2017 and the recall is currently terminated as of 12-18-2017 .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-0437-201712-22-201602-01-2017Class II6493 bottlesFurosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31.Terminated
D-0011-201609-25-201510-21-2015Class III11,110 bottlesFUROSEMIDE 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.Terminated
D-0012-201609-25-201510-21-2015Class III5,160 bottlesFUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4299-31, UPC 3 0054-4299-31 2.Terminated

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.