Padagis US LLC
Padagis US LLC appears in FDA public data with 8 recalls, 0 510(k) clearances, 11 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0677-2026, Class II) was initiated on June 23, 2026.
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 0
- Inspections
- 11
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0677-2026 | Class II | Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by P | June 23, 2026 |
| D-0246-2025 | Class II | Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured b | February 6, 2025 |
| D-0048-2025 | Class III | Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, M | October 11, 2024 |
| D-0139-2024 | Class II | Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By | November 1, 2023 |
| D-0081-2024 | Class II | Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, pa | September 28, 2023 |
| D-0464-2023 | Class III | Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per meter | February 21, 2023 |
| D-1497-2022 | Class II | Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 1045 | August 17, 2022 |
| D-0372-2022 | Class II | Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx only, Manufactu | December 27, 2021 |