Triamterene and Hydrochlorothiazide Capsules
Failed Impurity/Degradation Specifications
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 Triamterene. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Failed Impurity/Degradation Specifications
Failed Impurity/Degradation Specifications
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Subpotent Drug
Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
Labeling: Label Mixup: TRIAMTERENE/ HYDROCHLOROTHIAZIDE, Tablet, 37.5 mg/25 mg may have potentially been mislabeled as the following drug: SEVELAMER HCL, Tablet 800 mg, NDC 58468002101, Pedigree: W002858, EXP: 6/7/2014.
Labeling: Label Mixup: TRIAMTERENE/HCTZ, Tablet, 37.5 mg/25 mg may have potentially been mislabeled as the following drug: CAFFEINE, Tablet, 100 mg (1/2 of 200 mg), NDC 24385060173, Pedigree: AD30028_31, EXP: 5/8/2014.
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