Padagis Recalls Nystatin Cream Nationwide Over Subpotency Issue

Padagis US LLC has voluntarily recalled 180,936 tubes of Nystatin Cream USP after long-term stability testing found the product was subpotent, meaning it may not contain enough active ingredient to work as intended. The recall affects product distributed nationwide across the United States and has been classified as a Class II event by the FDA.

What Products Are Being Recalled?

• Product: Nystatin Cream USP (100,000 USP Nystatin Units)
• Net Weight: 15 g tube, Rx only
• NDC: 45802-059-35
• Manufactured by: Padagis, Yeruham, Israel
• Lot Number: 205060
• Expiration Date: 09/30/2027
• Quantity: 180,936 tubes

The recalled cream was distributed to pharmacies and healthcare providers throughout the United States.

Why Was This Recall Issued?

The recall was initiated after low out-of-specification assay results were discovered during long-term stability testing. This means the concentration of the active ingredient, nystatin, fell below required levels, resulting in a subpotent drug. Nystatin Cream is used to treat fungal infections of the skin, and reduced potency could compromise its ability to effectively treat these infections.

Who Is Affected?

This recall affects patients who have been prescribed Nystatin Cream USP with lot number 205060 and an expiration date of 09/30/2027, distributed under NDC 45802-059-35. Pharmacies, healthcare facilities, and individual consumers who received product from this specific lot across the United States may be impacted.

What Should You Do?

• Check the lot number and NDC on your Nystatin Cream tube against the recalled information above.
• If you have product from the affected lot, contact your pharmacist or healthcare provider before discontinuing use, since untreated fungal infections can worsen.
• Do not stop treatment abruptly without medical guidance.
• Return the affected product to your pharmacy or as directed by your healthcare provider.
• Report any adverse effects to the FDA MedWatch program.
• For questions, contact Padagis US LLC at their Minneapolis, MN headquarters.

Official Statement

According to the FDA enforcement report, this is a voluntary, firm-initiated recall by Padagis US LLC. The company notified consignees by letter. No press release has been issued for this recall, and the recall remains ongoing as of the latest classification date. The FDA has classified this as a Class II recall, indicating the product may cause temporary or medically reversible adverse health consequences, with the probability of serious harm considered remote.