Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g
Recalled by Padagis US LLC
Class II — moderate
Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Padagis US LLC has recalled Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on July 22, 2026 and was initiated on June 23, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, with approximately 180,936 tubes affected. The company behind the recall is Padagis US LLC, based in Minneapolis, MN. The FDA describes the product as: “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”
Why was Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g recalled?
According to the FDA, the stated reason for the recall is: “Subpotent Drug: Low out of specification assay results performed during long-term stability testing.” In plain terms, this recall relates to a potency or effectiveness issue.
This recall means the medicine may be stronger or weaker than its label says, or may not release its ingredient the way it should. That matters because too little medicine may not treat the condition, and too much can cause side effects. Anyone taking an affected product is generally advised to consult their pharmacist or doctor about a replacement.
What should you do?
If you think you may have bought Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, compare it against the product description and identifying codes (Lot #: 205060, Exp 09/30/2027) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Padagis US LLC or your local health authority.
About this recall
This recall was distributed in MN. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Who this recall affects
This recall matters to anyone who bought Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g. Even if you feel fine, it's worth checking what you have on hand rather than assuming you were missed.
Distribution listed in the notice: USA Nationwide.
What potency or effectiveness issue actually means
This recall means the medicine may be stronger or weaker than its label says, or may not release its ingredient the way it should. That matters because too little medicine may not treat the condition, and too much can cause side effects. Anyone taking an affected product is generally advised to consult their pharmacist or doctor about a replacement.
In this case, the concern applies specifically to Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g from Padagis US LLC — not to the wider category of products. Similar items from other brands aren't part of this recall.
How to check whether you have it
On medicine bottles, the lot number and expiration date are printed on the pharmacy label or stamped directly on the manufacturer's bottle — often near the bottom edge or on the back. If a pharmacy label covers it, your pharmacist can look up the lot they dispensed.
Compare what you find against the identifying details in this recall: Lot #: 205060, Exp 09/30/2027
What to do if you already bought it
Do not stop taking a prescribed medicine on your own because of a recall — for many conditions, an interrupted dose carries its own risk.
Instead, check the lot number against the details above and contact your pharmacist, who can confirm what they dispensed and arrange a replacement.
If you've had an unexpected reaction, contact your healthcare provider. Problems can also be reported to the FDA's MedWatch program.
Full recall details
- Status
- Ongoing
- Date reported
- July 22, 2026
- Recall started
- June 23, 2026
- Distributed in
- MN
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g recalled?+
According to the FDA: Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
How serious is this recall?+
Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
What should I do if I have Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0677-2026. Information last synced from the FDA on July 27, 2026.