Sun Pharmaceutical Industries recall: Nystatin Cream
Sun Pharmaceutical Industries INC is recalling Nystatin Cream – N/A. The U.S. Food and Drug Administration published the recall on September 23, 2026; it began on September 14, 2026. Distributed nationwide.
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| Product | Nystatin Cream |
| Brand | Sun Pharmaceutical Industries |
| Company | Sun Pharmaceutical Industries INC |
| Type | Drugs |
| Classification | Not Yet Classified |
| Recall date | September 14, 2026 |
| Published by FDA | September 23, 2026 |
| Quantity | N/A |
| Recall ID | 99876 |
Recalled 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
- FDA recall number
- N/A
- Codes, lots and dates
- LOT AD49605, LOT AD49606; Exp. 05/31/2027
- Quantity
- N/A
- Classification
- Not Yet Classified
Identifiers and details
- FDA event ID
- 99876
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Princeton, NJ, United States
Why it was recalled
The reason the FDA lists: “Failed Stability Specifications”
Where it was sold
Nationwide. Distribution as the FDA records it: “U.S. Nationwide.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99876, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other Sun Pharmaceutical Industries recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Aug 26, 2026 | manufacturing-practice violations Serious | FDA Class II |
Other drug recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Oct 7, 2026 | Failed Dissolution Specifications: below specification Serious | FDA Class II | |
| Oct 7, 2026 | Crystallization Serious | FDA Class II | |
| Oct 7, 2026 | Failed dissolution specifications. Serious | FDA Class II | |
| Oct 7, 2026 | Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient ou… Serious | FDA Class II | |
| Oct 7, 2026 | a sterility problem Serious | FDA Class II | |
| Oct 7, 2026 | Defective Container; packets were found to be either empty or partially full. Serious | FDA Class II |
About this recall
Is Sun Pharmaceutical Industries Nystatin Cream recalled?
Yes. Sun Pharmaceutical Industries INC recalled it on September 14, 2026; FDA published it September 23, 2026 (Not Yet Classified). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Failed Stability Specifications
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.