Quick Facts at a Glance
- Recall Date
- May 14, 2026
- Hazard Level
- HIGH
- Brands
- NICOTINE, Rugby Laboratories
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- NICOTINE, Rugby Laboratories
- Model numbers
- Lot #: 56841, Expires: 03/2028
- UPC codes
- 0536-5894, 0536-5896, 0536-5895, 0536-5896-53, 0536-5896-88, 0536-5896-71, 0536-5895-53, 0536-5895-88 +3 more
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
May 14, 2026
Reported by FDA DRUG
June 3, 2026
RecallRadar source check
June 10, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact AVEVA Drug Delivery Systems, Inc. or your healthcare provider for guidance. Notification method: Letter
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Full 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.. Generic: NICOTINE; Brand: NICOTINE. Reason: Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.. Classification: Class III. Quantity: 59,808 pouches (4,272 Individual Folding Carton (IFC)). Distribution: Nationwide within the U.S
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Safety Guide
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Read: How to Get Refunds and ReplacementsWant to Know First?
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