Bumetanide Tablets USP 0 — Class III drug recall D-341-2014
Terminated recall by Sandoz Inc, reported 2013-12-18, distributed nationwide. Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability
| Recall number | D-341-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz Inc, Wilson, NC, United States |
| Recall initiated | 2013-11-06 |
| Classified | 2013-12-06 |
| Reported by FDA | 2013-12-18 |
| Terminated | 2014-05-29 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 00185-0128, 00185-0128-01, 00185-0128-05, 00185-0129, 00185-0129-01, 00185-0129-05, 00185-0130, 00185-0130-01, 00185-0130-05 |
Product
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
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.
Machine access
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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.