Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Bumetanide Tablets USP 0.5 mg. Rx Only Recalled by Sandoz Inc Due to Failed Moisture Limit; Out of Specification (OOS) results...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sandoz Inc directly.
Affected Products
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
Quantity: 11,496 bottles (100 count) and 62 bottles (500 count)
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sandoz Inc
Sandoz Inc has 30 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report