Nicotine Transdermal System Patches Recalled Due to Failed Impurities/Degradation Specifications

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class III recall for nicotine transdermal system patches, 14mg. The affected batch has been identified as Lot 56841 (expires March 2028), affecting 59 808 pouches.
• The recall was initiated by Aveva Drug Delivery Systems, Inc due to failed impurities/degradation specifications, a quality issue that is not likely to cause adverse health consequences.
• Nicotine patches are used to help people stop smoking by reducing withdrawal symptoms.

The FDA has issued a Class III recall for nicotine transdermal system patches, 14mg, affecting 59 808 pouches. This medication is distributed nationwide by Rugby Laboratories in Indianapolis, Indiana, and is being recalled by Aveva Drug Delivery Systems, Inc based in Miramar, Florida. The recall was initiated on May 14, 2026, and received a Class III classification on May 26, 2026. A Class III classification means the use of this product is not likely to cause adverse health consequences.

The recall was initiated due to the product’s failure to meet impurities/degradation specifications—specifically the presence of elevated levels of oxidative-related impurities. This deficiency affects Lot 56841, which will expire in March 2028. Aveva Drug Delivery Systems sent out a public notice via letter; no public press release has been issued for this recall.

Nicotine patches are used to treat withdrawal symptoms and help people quit smoking. Pharmacists should identify and quarantine Lot 56841, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. June 3, 2026. Accessed June 3, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=220309