Nicotine Patch
FDA Recall NDC 0536-5894
Latest: Class III · Status: Ongoing · Initiated May 14, 2026 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Nicotine (NDC 0536-5894). A significant event, classified as Class III, was initiated on May 14, 2026 by Rugby Laboratories. The reported reason for this action was: "Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
May 14, 2026
Jun 03, 2026
59,808 pouches (4,272 Individual Folding Carton (IFC))
Recall Profile & Regulatory Data
Event ID
98972
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
AVEVA Drug Delivery Systems, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the U.S
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.
Batch or Lot Expiration Information
Lot# : 56841, Expires: 03/2028
Affected Packages Involved in this Recall
0536-5896-53Nicotine
0536-5896-88Nicotine
0536-5896-71Nicotine
0536-5895-53Nicotine
0536-5895-88Nicotine
0536-5895-71Nicotine
0536-5894-53Nicotine
0536-5894-88Nicotine
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
