Padagis US Recalls
8 recalls on record · January 19, 2022 to July 22, 2026 · Drugs
Recalls by year
22
23
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 22, 2026DrugsFDA
Padagis US LLC recalls Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Isr
Hazard: Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
March 5, 2025DrugsFDA
Padagis US LLC recalls Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham,
Hazard: Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
November 27, 2024DrugsFDA
Padagis US LLC recalls Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427
Hazard: Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
December 13, 2023DrugsFDA
Padagis US LLC recalls Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratori
Hazard: Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
November 8, 2023DrugsFDA
Padagis US LLC recalls Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefille
Hazard: Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
March 22, 2023DrugsFDA
Padagis US LLC recalls Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Onl
Hazard: Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.
September 7, 2022DrugsFDA
Padagis US LLC recalls Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Pe
Hazard: CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
January 19, 2022DrugsFDA
Padagis US LLC recalls Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx only, Manufactured by Perrigo, Yeru
Hazard: Defective Delivery System