Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Isr
Summary
The FDA issued a Class II for Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tub by Padagis US LLC. Reason: Subpotent Drug: Low out of specification assay results performed during long-term stability testing..
Details
Source
Drug Recall
External ID
D-0677-2026
Action Date
2026-07-22
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot #: 205060, Exp 09/30/2027
Quantity Affected: 180,936 tubes
Reason for Recall
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-23
Company
Minneapolis, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 28 drug recalls issued in the same week, part of 77 drug-related FDA actions this month.
Padagis US LLC has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (Padagis US LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Padagis US LLC have FDA actions?
Padagis US LLC has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0677-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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