FDA-Drug2026-07-22Class IICHEMICAL
Padagis Nystatin Cream recalled for subpotent drug — low assay results
What this means
Padagis Nystatin Cream USP (100,000 units, 15 g tube, lot #205060, expiring 09/30/2027) has been recalled because stability testing found the active ingredient fell below the required strength specification. The cream may not work as effectively as intended to treat fungal infections.
- If you have this medication, contact your pharmacy or prescriber for guidance before using or discarding it.
- Do not use the product if you have lot #205060 with expiration 09/30/2027.
The agency's original wording
Hazard
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Intended for
All ages
Illnesses reported
None reported
Sold states
USA Nationwide
Affected count
180,936 tubes
Manufactured in
3940 Quebec Ave N, Minneapolis, MN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0677-2026Want us to check the next one for you?
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