Not Yet ClassifiedDrug
Nystatin Cream recall
Summary
SUN PHARMACEUTICAL INDUSTRIES INC is recalling Nystatin Cream (drug). According to the FDA report, the reason is: Failed Stability Specifications. The FDA rated this a Not Yet Classified: Recall status: Ongoing.
Details from the FDA report
- Product
- 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
- Reason
- Failed Stability Specifications
- Lot / code info
- LOT AD49605, LOT AD49606; Exp. 05/31/2027
- Quantity
- N/A
- Distribution
- U.S. Nationwide.
- Recalling company
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ United States
- Recall started
- September 14, 2026
- FDA report date
- September 23, 2026
- Classification
- Not Yet Classified:
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- N/A
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (SUN PHARMACEUTICAL INDUSTRIES INC) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.