Records by Year Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
3 2017 3
1 2018 2018 1 vs 2017−2
0 2019 0 vs 2018−1
3 2020 2020 3 vs 2019+3
2 2021 2 vs 2020−1
3 2022 2022 3 vs 2021+1
5 2023 5 vs 2022+2
2 2024 2024 2 vs 2023−3
2 2025 2 vs 2024+0
3 2026 2026 to date 3
Latest Records Newest first across sources; each opens the record Date Record Source Jun 23, 2026 Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-3 Class II · Subpotent Drug: Low out of specification assay results performed during long-term stability testing. Drug recalls Feb 6, 2025 Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0 Class II · Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product. Drug recalls Oct 11, 2024 Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427. NDC: 45802-0063-05 Class III · Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test duri Drug recalls Nov 1, 2023 Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratories (India) Pvt. Ltd. Class II · Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules Drug recalls Sep 28, 2023 Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per car Class II · Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Drug recalls Feb 21, 2023 Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Only, Manufactured by D Class III · Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not Drug recalls Aug 17, 2022 Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Perrigo, Allegan, MI 4 Class II · CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness. Drug recalls Dec 27, 2021 Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx only, Manufactured by Perrigo, Yeruham, Israel; Distrib Class II · Defective Delivery System Drug recalls
Names and Identifiers
Appears as PADAGIS US Padagis US LLC Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
