Minneapolis, MN, United States
Padagis US LLC recalls
8 recalls recorded since 2018, most recently on 23 June 2026. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls8
Ongoing (FDA)4
Terminated or completed4
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 23 June 2026
- Reason
- Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0677-2026
- Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35
Completed Class II Drugs
- Recall started
- 6 February 2025
- Reason
- Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0246-2025
- Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30
Terminated Class III Drugs
- Recall started
- 11 October 2024
- Terminated
- 29 September 2025
- Reason
- Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0048-2025
- Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427. NDC: 45802-0063-05
Ongoing Class II Drugs
- Recall started
- 1 November 2023
- Reason
- Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0139-2024
- Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun-248 197 Uttarakhand,
Ongoing Class II Drugs
- Recall started
- 28 September 2023
- Reason
- Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0081-2024
- Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per carton, Rx Only, Manufactured By Padagis, Yeruham, Israel; Distributed By: Padagis,
Ongoing Class III Drugs
- Recall started
- 21 February 2023
- Reason
- 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.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0464-2023
- 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 DPT Laboratories, Ltd San Antonio, TX 78215, Manufactured for: Perrigo, Allegan,
Terminated Class II Drugs
- Recall started
- 17 August 2022
- Terminated
- 28 September 2023
- Reason
- CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1497-2022
- Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Perrigo, Allegan, MI 49010, NDC 45802-064-36.
Terminated Class II Drugs
- Recall started
- 27 December 2021
- Terminated
- 28 September 2023
- Reason
- Defective Delivery System
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0372-2022
- Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx only, Manufactured by Perrigo, Yeruham, Israel; Distributed by Perrigo, Allegan, MI 49010, NDC 45802-210-02
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.