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Nystatin Cream USP
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DRUG RECALLMODERATE

Nystatin Cream USP

Padagis is recalling 15 g tubes of Nystatin Cream USP due to subpotent drug results found during stability testing.

What to do

Contact your healthcare provider or pharmacist if you have concerns about your medication. Do not use the affected product.

Recalled
Listed
Updated
Recall No.
D-0677-2026
Agency
FDA
Firm
Padagis US LLC
Recall ID
99283
Status
ONGOING

Recall at a glance

Quantity recalled
180,936 tubes

Why it was recalled

Padagis is recalling Nystatin Cream USP due to subpotent drug results identified during long-term stability testing. The affected product is a 15 g tube containing 100,000 USP Nystatin Units.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube

Lot code
205060, 2027
NDC / UPC
NDC 45802-059-35

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Other Drug Potency recalls

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Editorial summary by Recall Canary · summary updated 2026-07-14 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification