Nicotine Transdermal System Patch recall
FDA recall D-0550-2026 · initiated May 14, 2026
AVEVA Drug Delivery Systems, Inc. recalled Nicotine Transdermal System Patch in May 2026 — an FDA Class III recall (D-0550-2026) because Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Unlikely to cause harm but violates FDA labeling or manufacturing 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.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 59,808 pouches (4,272 Individual Folding Carton (IFC))
Details
- Product
- 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.
- Recalling company
- AVEVA Drug Delivery Systems, Inc.
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the U.S
- Initiated
- May 14, 2026
- FDA report date
- Jun 3, 2026
Frequently asked
- Was Nicotine Transdermal System Patch recalled?
- AVEVA Drug Delivery Systems, Inc. recalled Nicotine Transdermal System Patch in May 2026 — an FDA Class III recall (D-0550-2026) because Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Nicotine Transdermal System Patch recalled?
- Per the FDA enforcement record, the reason for recall D-0550-2026 was: Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
- Is a recalled Nicotine Transdermal System Patch dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Nicotine Transdermal System Patch are affected?
- Distributed: Nationwide within the U.S. The recall covers these lots — Lot #: 56841, Expires: 03/2028. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0550-2026.