Notice names this product. Padagis US’s Nystatin Cream USP is named in FDA Class II recall D-0677-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Subpotent Drug: Low out of specification assay results performed during long-term stability testing. Identifying details: Lot #: 205060, Exp 09/30/2027. Units affected: 180,936 tubes. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
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
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Company / brand: Padagis US
Affected product: Nystatin Cream USP
Official ID D-0677-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.