Drug recall: Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Isr

FDA enforcement event 99283 · Class II · initiated 23 Jun 2026 · status Ongoing

DrugVoluntary: Firm initiated1 product recordMinneapolis, MN

Padagis US LLC (Minneapolis, MN) initiated this drug recall on 23 Jun 2026; FDA lists 1 product record under event 99283, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 74% of the 234 drug enforcement events initiated in 2026 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Padagis US LLC has 8 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Padagis US LLC, Minneapolis, MN.

Reason for recall

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

Distribution

"USA Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
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	180,936 tubes	Class II	Ongoing	22 Jul 2026

Context

74%of 2026 drug events are Class II234 events that year

1product record in this eventfirm median: 1

8events on this register for the firm

Other enforcement events for Padagis US LLC

Initiated	Product (first record)	Type	Class	Records
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,	Drug	Class II	1
11 Oct 2024	Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427	Drug	Class III	1
1 Nov 2023	Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratorie	Drug	Class II	1
28 Sep 2023	Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefille	Drug	Class II	1
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 Onl	Drug	Class III	1
17 Aug 2022	Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Pe	Drug	Class II	1
27 Dec 2021	Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx only, Manufactured by Perrigo, Yeru	Drug	Class II	1

All 8 events for Padagis US LLC

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Subpotent Drug: Low out of specification assay results performed during long-term stability testing."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "USA Nationwide"

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.