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Class II · ModerateActive recall

Nystatin

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 205060, Exp 09/30/2027
Where it was soldUSA Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byPadagis, Yeruham, Israel foreign manufacturer
Brand nameNYSTATIN
Generic nameNYSTATIN
Active ingredient(s)NYSTATIN
Distributed by / forPadagis US LLC
NDC45802-059-35
Show the full FDA record
Full product labelNystatin 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
Recalling firmPadagis US LLC
DistributionUSA Nationwide
Quantity180,936 tubes
Recall initiated2026-06-23
Report date2026-07-22
Recall completed—
Recall numberD-0677-2026
ClassificationClass II
FDA statusOngoing
Origin on fileMinneapolis MN United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.