Nystatin Cream USP recall
FDA recall D-0677-2026 · initiated Jun 23, 2026
Padagis US LLC recalled Nystatin Cream USP in Jun 2026 — an FDA Class II recall (D-0677-2026) because Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 180,936 tubes
Details
- Product
- 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
- Recalling company
- Padagis US
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- Jun 23, 2026
- FDA report date
- Jul 22, 2026
Frequently asked
- Was Nystatin Cream USP recalled?
- Padagis US LLC recalled Nystatin Cream USP in Jun 2026 — an FDA Class II recall (D-0677-2026) because Subpotent Drug: Low out of specification assay results performed during long-term stability testing. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Nystatin Cream USP recalled?
- Per the FDA enforcement record, the reason for recall D-0677-2026 was: Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
- Is a recalled Nystatin Cream USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Nystatin Cream USP are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot #: 205060, Exp 09/30/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0677-2026.