NICOTINE
Recalling Firm / Manufacturer: AVEVA Drug Delivery Systems, Inc.
(Miramar, FL, United States)
FDA Recall Number: D-0550-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
NICOTINE
Generic Name
NICOTINE
Active Substance(s)
Nicotine
Administration Route
Transdermal
National Drug Code (NDC)
0536-5894
Total Quantity Recalled
59,808 pouches (4,272 Individual Folding Carton (IFC))
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Full Product Description
Packaging specifications and labeling details
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.
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class III
Current Action Status
Ongoing
FDA Enforcement Report Date
June 03, 2026
Firm Initiation Date
May 14, 2026
FDA Classification Date
May 26, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot #: 56841, Expires: 03/2028
Distribution Information
Geographic scope of affected shipments
Nationwide within the U.S
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Advisory Notice
This Class III recall involves technical or packaging non-conformities that are not expected to cause adverse health consequences. Consult your pharmacist if you have questions.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0550-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508602UTCC