CLASS III Drug recall · Reported 21 Oct 2015 · FDA Enforcement Report
Furosemide Tablets USP, 20 mg recalled by Boehringer Ingelheim Roxane
Boehringer Ingelheim Roxane is recalling Furosemide Tablets USP, 20 mg, distributed nationwide in the US. The recall was initiated on 25 Sep 2015 and the FDA has classified it as Class III.
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-0011-2016
- FDA event ID
- 72234
- Recalling firm
- Boehringer Ingelheim Roxane, Columbus, OH
- Brand
- Furosemide
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 25 Sep 2015
- FDA classified
- 9 Oct 2015
- Reported
- 21 Oct 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 25 Sep 2015 | Recall initiated by company | |
| 9 Oct 2015 | Classified by FDA | +14 days |
| 21 Oct 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #: 559660P, 559661P, Exp 03/17
Where was it sold?
Nationwide and Puerto Rico
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
Other products in this recall event
1 other product · FDA event 72234| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Furosemide Tablets USP, 40 mg recalled by Boehringer Ingelheim RoxaneFurosemide | Boehringer Ingelheim Roxane | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Boehringer Ingelheim Roxane
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Furosemide Tablets USP, 40 mg recalled by Boehringer Ingelheim RoxaneFurosemide | Boehringer Ingelheim Roxane | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Combivent Respimat (ipratropium bromide recalledCombivent Respimat | Boehringer Ingelheim Roxane | Other | Nationwide |
| Drug | CLASS II | Acarbose Tablets 50 mg a) Unit Dose Tablets per, b) recalledAcarbose | Boehringer Ingelheim Roxane | Potency & Assay | Nationwide |
| Drug | CLASS III | Oxycodone Hydrochloride C II Oral Solution USP, 5 mg/ Vial recalled | Boehringer Ingelheim Roxane | Potency & Assay | Nationwide |
| Drug | CLASS II | Calcitriol Oral Solution 1 mcg/mL recalledCalcitriol | Boehringer Ingelheim Roxane | 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 Tablets USP, 20 mg recalled by Roxane LaboratoriesFurosemide | Roxane Laboratories | 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 |