--- title: "Padagis US LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Padagis US LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/padagis-us-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Padagis US LLC recall records **4** reported ongoing 8 records in this archive. Latest source date Jun 23, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jun 23, 2026 FDA drug enforcement ### [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](https://isitonrecall.com/recall/fda-drug-d-0677-2026-nystatin-cream-usp-100-000-usp-nystatin-units-net-wt-15-g-rx-only-15-g-tube-manufactured-by-padagis/) Subpotent Drug: Low out of specification assay results performed during long-term stability testing. Class II Reported ongoing Distribution: USA Nationwide [Official source for Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured b...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0677-2026%22) Feb 6, 2025 FDA drug enforcement ### [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](https://isitonrecall.com/recall/fda-drug-d-0246-2025-estradiol-gel-0-1-0-25-mg-g-30-packets-per-carton-rx-only-for-topical-use-only-manufactured-by-padag/) Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product. Class II Reported completed Distribution: Nationwide in the USA [Official source for Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufacture...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0246-2025%22) Oct 11, 2024 FDA drug enforcement ### [Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427. NDC: 45802-0063-05](https://isitonrecall.com/recall/fda-drug-d-0048-2025-triamcinolone-acetonide-cream-usp-0-025-1-lb-454-g-per-jar-rx-only-manufactured-by-padagis-minneapol/) Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing. Class III Reported terminated Distribution: Nationwide in the USA [Official source for Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0048-2025%22) Nov 1, 2023 FDA drug enforcement ### [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 Indu...](https://isitonrecall.com/recall/fda-drug-d-0139-2024-trospium-chloride-extended-release-capsules-60-mg-30-capsules-per-bottle-rx-only-manufactured-by-sid/) Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0139-2024%22) Sep 28, 2023 FDA drug enforcement ### [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...](https://isitonrecall.com/recall/fda-drug-d-0081-2024-gynazole-1-butoconazole-nitrate-vaginal-cream-usp-2-net-wt-5-8-g-per-pre-filled-applicator-packaged/) Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process. Class II Reported ongoing Distribution: Nationwide within the United States [Official source for Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator,...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0081-2024%22) Feb 21, 2023 FDA drug enforcement ### [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 ...](https://isitonrecall.com/recall/fda-drug-d-0464-2023-evamist-estradiol-transdermal-spray-1-53-mg-of-estradiol-per-spray-0-27-fl-oz-8-1-ml-per-metered-dos/) 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. Class III Reported ongoing Distribution: Nationwide in the USA [Official source for Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per me...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0464-2023%22) Aug 17, 2022 FDA drug enforcement ### [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.](https://isitonrecall.com/recall/fda-drug-d-1497-2022-triamcinolone-acetonide-cream-usp-0-1-80-g-tube-rx-only-manufactured-by-perrigo-bronx-ny-10457-distr/) CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness. Class II Reported terminated Distribution: Nationwide in the USA [Official source for Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 1...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1497-2022%22) Dec 27, 2021 FDA drug enforcement ### [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, N...](https://isitonrecall.com/recall/fda-drug-d-0372-2022-nitroglycerin-lingual-spray-400-mcg-per-spray-200-metered-sprays-12-g-bottles-rx-only-manufactured-b/) Defective Delivery System Class II Reported terminated Distribution: Nationwide USA [Official source for Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx only, Manufa...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0372-2022%22) ## Reasons in these listed records - Subpotent Drug: Low out of specification assay results performed during long-term stability testing. - Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product. - Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing. - Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules These examples come from this result page and are not a ranking of every recall reason. ## Checking Padagis US LLC ### Is there a recall on padagis us llc right now? This archive contains 8 records, including 4 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Padagis US LLC](https://isitonrecall.com/check/?q=Padagis%20US%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)