Class III · Low risk
Nicotine Gum
Labeling: Incorrect or Missing Package Insert: The package insert included in the finished product is for the Canadian market and is not part of the current approved drug labeling.
Nicotine Transdermal System Patch
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
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.
Affected NDC
0536-5895-88
Compare with the code on your package — it is the most precise check available.
Drug: Nicotine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Nicotine NDC 00536-5895 |
14 mg/24h | Patch Transdermal |
Rugby Laboratories | OTC |
- Recalling firm
- AVEVA Drug Delivery Systems, Inc.
- NDC code
- 0536-5895-88
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0550-2026 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Nicotine recalls
See all
Class III · Low risk
Nicotine Polacrilex Lozenge
Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.
Class III · Low risk
Nicorette Lozenge and NicoDerm CQ
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III · Low risk
Nicorette (nicotine polacrilex)
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III · Low risk
Nicorette (nicotine polacrilex)
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Other recalls by AVEVA Drug Delivery Systems, Inc.
All 2026 recalls
Class III · Low risk
Buprenorphine Transdermal System
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
Class III · Low risk
Buprenorphine Transdermal System
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
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