CLASS III Drug recall · Reported 18 Dec 2013 · FDA Enforcement Report
Bumetanide Tablets USP 0.5 mg recalled by Sandoz
Sandoz is recalling Bumetanide Tablets USP 0.5 mg, distributed nationwide in the US. The recall was initiated on 6 Nov 2013 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-341-2014
- FDA event ID
- 66791
- Recalling firm
- Sandoz, Wilson, NC
- Brand
- Bumetanide
- Manufacturer
- Sandoz Inc
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 6 Nov 2013
- FDA classified
- 6 Dec 2013
- Reported
- 18 Dec 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 6 Nov 2013 | Recall initiated by company | |
| 6 Dec 2013 | Classified by FDA | +30 days |
| 18 Dec 2013 | 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
Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bottle, Sandoz Inc., Princeton, NJ 08540, NDC a) 0185-0128-01, b) 0185-0128-05
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.
Which lots are affected?
Lot #: a) CU6131, b) CW1161
Where was it sold?
Nationwide
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.
More recalls from Sandoz
All 59| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Focalin XR (dexmethylphenidate HCl) 5 mg recalled by SandozFocalin | Sandoz | Other | Nationwide |
| Drug | CLASS II | Cyclophosphamide Injection 500 mg/ (100 mg/mL), Hazardous Drug recalledCyclophosphamide | Sandoz | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension recalledCiprofloxacin And Dexamethasone | Sandoz | Temperature Abuse | CA |
| Drug | CLASS I | Buffered Penicillin G Potassium for Injection recalled by SandozPenicillin G Potassium | Sandoz | Labeling Errors | Nationwide |
| Drug | CLASS I | Cefazolin for Injection, USP per vial, Sterile recalled by SandozCefazolin | Sandoz | Packaging Defects | Nationwide |
Other Bumetanide recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bumetanide Tablets, USP, 2 mg recalled by Cardinal Healthcare | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Bumetanide Tablets, USP, 1 mg recalled by Upsher Smith Laboratories | Upsher Smith Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Bumetanide Tablets, USP, 2 mg recalled by Upsher Smith Laboratories | Upsher Smith Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Bumetanide, Tablet, 1 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Bumetanide, Tablet, 0.5 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |