Information
AVEVA Drug Delivery Systems Recalls Nicotine Transdermal System Patch
This is a Class III recall. This product is unlikely to cause adverse health reactions but violates FDA regulations.
Source: FDA
InfoRecall #D-0550-2026Drug / Pharmaceutical
AVEVA Drug Delivery Systems Recalls Nicotine Transdermal System Patch
AVEVA Drug Delivery Systems, Inc. · Class III — Regulatory
Product Description
Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88.
Reason for Recall
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
FDA Classification
Class III — Regulatory
A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Distribution
Nationwide within the U.S
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A regulatory compliance recall has been issued for a pharmaceutical product from AVEVA Drug Delivery Systems, Inc. The FDA classified this as Class III on May 14, 2026 affecting 59,808 pouches (4,272 Individual Folding Carton (IFC)). Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units. It was distributed nationwide. While this classification indicates a low probability of adverse health effects, consumers should be aware of the recall and follow any instructions from the manufacturer.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.