Padagis US LLC

FDA recalling firm · 8 enforcement events · 8 product records · 2021–2026 · MN

Padagis US LLC has 8 FDA enforcement events on this register (8 product records) between 2021 and 2026: 8 drug; the busiest year was 2023 with 3.

0% of its events are Class I; the most common class is Class II (6). 4 events are listed as ongoing; the recalling firm's address is in MN.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
23 Jun 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	Drug	Class II	1	Ongoing
6 Feb 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	Drug	Class II	1	Completed
11 Oct 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	Drug	Class III	1	Terminated
1 Nov 2023	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, India Distributed By: Padagis, Allegan, MI 49010. NDC: 0574-0118-30	Drug	Class II	1	Ongoing
28 Sep 2023	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, Allegan, MI 49010. NDC: 45802-396-01	Drug	Class II	1	Ongoing
21 Feb 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, Minnapolis, MN 55427, NDC: 0574-2067-27	Drug	Class III	1	Ongoing
17 Aug 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.	Drug	Class II	1	Terminated
27 Dec 2021	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	Drug	Class II	1	Terminated

By type and class

Drug8

Class II6

Class III2

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Padagis US LLC by year initiated.

Questions and answers

How many FDA recalls has Padagis US LLC had?

8 enforcement events (8 product records) on this register, 2021–2026: 8 drug.

Are any Padagis US LLC recalls ongoing?

4 events are listed as ongoing in the current openFDA export.

What class are Padagis US LLC recalls?

6 Class II, 2 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.