Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15… was recalled on June 23, 2026 in cooperation with the U.S. Food and Drug Administration because subpotent Drug: Low out of specification assay results performed during long-term stability testing..
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
Lot #: 205060, Exp 09/30/2027
Units affected: 180,936 tubes
Where it was sold: USA Nationwide
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Padagis US LLC
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
View official notice →The recalled sweaters violate the mandatory standard for clothing textiles, posing a risk of serious burn injuries or death.
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
Lack of Assurance of Sterility
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
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