Nystatin Cream, USP, 15 g per tube, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761; Di
Summary
The FDA issued a recall for Nystatin Cream, USP, 15 g per tube, Rx only, Mfd. by: Taro Pharmaceutical Indust by SUN PHARMACEUTICAL INDUSTRIES INC. Reason: Failed Stability Specifications.
Details
Source
Drug Recall
External ID
N/A
Action Date
2026-09-23
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: LOT AD49605, LOT AD49606; Exp. 05/31/2027
Quantity Affected: N/A
Reason for Recall
Failed Stability Specifications
Distribution
U.S. Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-14
Company
Princeton, NJ
Context & Analysis
This is a unclassified recall.
This was one of 17 drug recalls issued in the same week, part of 66 drug-related FDA actions this month.
SUN PHARMACEUTICAL INDUSTRIES INC has 87 FDA actions in our database, including 86 recalls and 1 clearance.
Frequently Asked Questions
What is a FDA recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SUN PHARMACEUTICAL INDUSTRIES INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SUN PHARMACEUTICAL INDUSTRIES INC have FDA actions?
SUN PHARMACEUTICAL INDUSTRIES INC has 87 FDA actions in our database, including 86 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "N/A" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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