Padagis US recalls
FDA enforcement reports naming Padagis US LLC as the recalling firm.
- Recall reports
- 8
- Class I (serious)
- 0
- Most recent report
- Jul 22, 2026
- Jul 22, 2026Nystatin Cream USP, (100,000 USP Nystatin Units)Drug · Padagis US LLCSubpotent Drug: Low out of specification assay results performed during long-term stability testing.Class II
- Mar 5, 2025Estradiol Gel, 0Drug · Padagis US LLCDefective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.Class II
- Nov 27, 2024Triamcinolone Acetonide Cream USP, 0Drug · Padagis US LLCSubpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.Class III
- Dec 13, 2023Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Ma…Drug · Padagis US LLCFailed Tablets/Capsules specifications; missing/broken/extra tablets within the capsulesClass II
- Nov 8, 2023Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%Drug · Padagis US LLCIncorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.Class II
- Mar 22, 2023Evamist (estradiol transdermal spray), 1Drug · Padagis US LLCFailed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.Class III
- Sep 7, 2022Triamcinolone Acetonide Cream USP, 0Drug · Padagis US LLCCGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.Class II
- Jan 19, 2022Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx on…Drug · Padagis US LLCDefective Delivery SystemClass II