Why it was recalled
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Product description
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 numbers, UPCs & expiration codes
Lot #: 205060, Exp 09/30/2027
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0677-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 23, 2026
- FDA report date
- Jul 22, 2026
- Quantity
- 180,936 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Padagis US LLC
Original FDA data
Every field from FDA enforcement report D-0677-2026, exactly as published.
Show all FDA fields
- City
- Minneapolis
- State
- MN
- Status
- Ongoing
- Country
- United States
- Event ID
- 99283
- Address
- 3940 Quebec Ave N
- Code information
- Lot #: 205060, Exp 09/30/2027
- Postal code
- 55427-1244
- Report date
- Jul 22, 2026
- Product type
- Drugs
- Recall number
- D-0677-2026
- Classification
- Class II
- Recalling firm
- Padagis US LLC
- Product quantity
- 180,936 tubes
- Reason for recall
- Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Jun 23, 2026
- Initial firm notification
- Letter
- Center classification date
- Jul 13, 2026