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Padagis US LLC FDA Recalls
8 recalls on file across drugs, 0 of them Class I and 4 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, IsrClass IIJun 23, 2026Subpotent Drug: Low out of specification assay results perfo |
| Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Class IIFeb 6, 2025Defective Container: Some packets may not be fully sealed, p |
| Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427Class IIIOct 11, 2024Subpotent and Superpotent Drug. Out of specification assay r |
| Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak LaboratoriClass IINov 1, 2023Failed Tablets/Capsules specifications; missing/broken/extra |
| Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilleClass IISep 28, 2023Incorrect Product Formulation: Hydrophilic Colloidal Silica |
| Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx OnlClass IIIFeb 21, 2023Failed Content Uniformity Specifications: The Spray Content |
| Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By PeClass IIAug 17, 2022CGMP Deviations: Product complaints reporting the product to |
| Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx only, Manufactured by Perrigo, YeruClass IIDec 27, 2021Defective Delivery System |