US Drug Recall Register
Class III · Low risk Terminated Initiated Nov 6, 2013 (13 years ago)

Bumetanide Tablets USP 0.5 mg. Rx Only

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was 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.

What was recalled

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

Recalling firm
Sandoz Inc
Origin
NC, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-341-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Bumetanide recalls

See all
Class II · Moderate risk Terminated

Bumetanide Tablets

Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Cardinal Healthcare D-0171-2024
Class II · Moderate risk Terminated

Bumetanide Tablets

Reason Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.

Upsher Smith Laboratories, Inc. NDC 0832-0542-11 D-0281-2019
Class II · Moderate risk Terminated

Bumetanide Tablets

Reason Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.

Upsher Smith Laboratories, Inc. NDC 0832-0541-11 D-0280-2019
Class II · Moderate risk Terminated

Bumetanide

Reason Labeling: Label Mixup: BUMETANIDE, Tablet, 1 mg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000815, Pedigree: W003218, EXP: 6/17/2014.

Aidapak Services, LLC D-838-2014
Class II · Moderate risk Terminated

Bumetanide

Reason Labeling: Label Mixup: BUMETANIDE, Tablet, 0.5 mg, Rx only may have potentially been mislabeled as the following drug: ERYTHROMYCIN DR EC, Tablet, 250 mg, NDC 24338012213, Pedigree: AD46426_13, EXP: 5/15/2014.

Aidapak Services, LLC D-837-2014