FDA Drugs recall ·
Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only… recall
- Recall number
- D-0677-2026
- Date
- (initiated June 23, 2026)
- Company / brand
- Padagis US LLC
3940 Quebec Ave N, Minneapolis, MN, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 180,936 tubes
- Hazard tags
- Potency
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 205060, Exp 09/30/2027
Distribution
USA Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0677-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.