Nystatin Cream Recalled Due to Subpotent Drug

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for nystatin cream, 15 g. The affected batch has been identified as Lot 205060 (expires September 2027), affecting 180 936 tubes.
• The recall was initiated by Padagis US, LLC due to a subpotent drug, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• Nystatin cream is used to treat fungal skin infections.

The FDA has issued a Class II recall for nystatin cream, 15 g, affecting 180 936 tubes. This product is being recalled by Padagis US, LLC based in Minneapolis, Minnesota. The recall was initiated on June 23, 2026, and received a Class II classification on July 13, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated due to a subpotent drug; during a long-term stability test, the product had low out-of-specification results. This deficiency affects Lot 205060, which will expire in September 2027. Padagis US sent out a public notice via letter; no press release has been issued for this recall.

Nystatin cream is used to treat fungal or yeast infections in the skin. Pharmacists should identify and quarantine Lot 205060, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. July 22, 2026. Accessed July 22, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221191