Why it was recalled
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
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.
Lot numbers, UPCs & expiration codes
Lot #: 56841, Expires: 03/2028
Where it was sold
Nationwide within the U.S
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0550-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- May 14, 2026
- FDA report date
- Jun 3, 2026
- Quantity
- 59,808 pouches (4,272 Individual Folding Carton (IFC))
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AVEVA Drug Delivery Systems, Inc.
Original FDA data
Every field from FDA enforcement report D-0550-2026, exactly as published.
Show all FDA fields
- City
- Miramar
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 98972
- Address
- 3250 Commerce Pkwy
- Code information
- Lot #: 56841, Expires: 03/2028
- Postal code
- 33025-3907
- Report date
- Jun 3, 2026
- Product type
- Drugs
- Recall number
- D-0550-2026
- Classification
- Class III
- Recalling firm
- AVEVA Drug Delivery Systems, Inc.
- Product quantity
- 59,808 pouches (4,272 Individual Folding Carton (IFC))
- Reason for recall
- Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide within the U.S
- Recall initiation date
- May 14, 2026
- Initial firm notification
- Letter
- Center classification date
- May 26, 2026