FDA-Drug2026-09-23Not Yet ClassifiedCHEMICAL
Sun Pharmaceutical Nystatin Cream recalled for failed stability specifications
What this means
Sun Pharmaceutical is recalling specific lots of Nystatin Cream, USP (15 g tubes) because the medication failed stability testing. This means the cream may not maintain its expected strength or safety over time. The affected lots are AD49605 and AD49606, with expiration dates of 05/31/2027.
- Check your prescription nystatin cream for lot number AD49605 or AD49606.
- Contact your pharmacy or doctor if you have one of these lots.
- Do not use the recalled cream; your pharmacy can provide a replacement or alternative.
The agency's original wording
Hazard
Failed Stability Specifications
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S. Nationwide.
Affected count
N/A
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
Nystatin Cream, USP, 15 g per tube, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761; Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC: 51672-1289-1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=99876More Sun Pharmaceutical recalls
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