Padagis recalls

8 official recalls and safety alerts involving Padagis since 2022-01, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Padagis or the relevant agency.

  1. 2026-07-22
  2. US
    Drugs & medicalClass II

    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, Israel, NDC…

    Subpotent Drug: Low out of specification assay results performed during long-term stability testing.

    FDA · DrugPadagis US LLCUSA NationwideOfficial notice →
  3. 2025-03-05
  4. US
    Drugs & medicalClass II

    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, Israel, NDC:…

    Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.

    FDA · DrugPadagis US LLCNationwide in the USAOfficial notice →
  5. 2024-11-27
  6. US
    Drugs & medicalClass III

    Padagis US LLC recalls Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427. NDC: 45802-0063-05

    Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.

    FDA · DrugPadagis US LLCNationwide in the USAOfficial notice →
  7. 2023-12-13
  8. US
    Drugs & medicalClass II

    Padagis US LLC recalls Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratories (India) Pvt.…

    Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules

    FDA · DrugPadagis US LLCNationwide in the USAOfficial notice →
  9. 2023-11-08
  10. US
    Drugs & medicalClass II

    Padagis US LLC recalls Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per…

    Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.

    FDA · DrugPadagis US LLCNationwide within the United StatesOfficial notice →
  11. 2023-03-22
  12. US
    Drugs & medicalClass III

    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 Only, Manufactured by…

    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.

    FDA · DrugPadagis US LLCNationwide in the USAOfficial notice →
  13. 2022-09-07
  14. US
    Drugs & medicalClass II

    Padagis US LLC recalls Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Perrigo, Allegan, MI…

    CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.

    FDA · DrugPadagis US LLCNationwide in the USAOfficial notice →
  15. 2022-01-19
  16. US