Class II · Moderate risk
Bumetanide Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Is Bumetanide recalled?
Not under an active recall.
Bumetanide was recalled 6 times in the past — all now closed. Most recent: Jan 26, 2022.
Most common reason: Impurity / degradation (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Bumetanide. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Bumetanide recalls on record
none so far in 2026; 6 on record, newest first
Class II · Moderate risk
Bumetanide Tablets
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Class II · Moderate risk
Bumetanide Tablets
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Class III · Low risk
Bumetanide Tablets USP 0.5 mg. Rx Only
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.
Class II · Moderate risk
Bumetanide
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.
Class II · Moderate risk
Bumetanide
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.
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