CLASS II Drug recall · Reported 1 Feb 2017 · FDA Enforcement Report
Furosemide Tablets USP, 20 mg recalled by Roxane Laboratories
Roxane Laboratories is recalling Furosemide Tablets USP, 20 mg, distributed nationwide in the US. The recall was initiated on 22 Dec 2016 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0437-2017
- FDA event ID
- 76142
- Recalling firm
- Roxane Laboratories, Columbus, OH
- Brand
- Furosemide
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Dec 2016
- FDA classified
- 23 Jan 2017
- Reported
- 1 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 22 Dec 2016 | Recall initiated by company | |
| 23 Jan 2017 | Classified by FDA | +32 days |
| 1 Feb 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
Product as listed by the FDA
Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
Which lots are affected?
Lot# 660833A, Exp 08/31/18
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Roxane Laboratories
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Azelastine Hydrochloride Nasal Solution (Nasal Spray) recalled | Roxane Laboratories | Potency & Assay | Nationwide |
Other Furosemide recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Furosemide Tablets, USP, 80 mg recalled by Leading PharmaFurosemide | Leading Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Furosemide Tablets, USP 40 mg recalled by Graviti PharmaceuticalsFurosemide | Graviti Pharmaceuticals Private | Other | Nationwide |
| Drug | CLASS II | Furosemide 20 mg/mL svn Sol, Rx recalled by Western Drug | Western Drug | Sterility | Nationwide |
| Drug | CLASS III | Furosemide Tablets USP, 40 mg recalled by Boehringer Ingelheim RoxaneFurosemide | Boehringer Ingelheim Roxane | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Furosemide Tablets USP, 20 mg recalled by Boehringer Ingelheim RoxaneFurosemide | Boehringer Ingelheim Roxane | Manufacturing (CGMP) Deviations | Nationwide |