FDA-Drug2026-06-03Class IIICHEMICAL
Aveva Nicotine Transdermal System 14 mg patch recalled for elevated impurities
What this means
AVEVA nicotine patches (14 mg) distributed by Rugby Laboratories have elevated levels of chemical impurities that exceed safety standards for shelf life. The issue was discovered during stability testing of specific lots. No injuries have been reported.
- Check if you have lot #56841 (expires 03/2028) — the NDC number is 0536-5895-88.
- If you have this lot, contact your pharmacist or doctor before using the patches.
- Do not throw patches away; ask your pharmacist how to return or dispose of them safely.
The agency's original wording
Hazard
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the U.S
Affected count
59,808 pouches (4,272 Individual Folding Carton (IFC))
Manufactured in
3250 Commerce Pkwy, Miramar, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0550-2026Want us to check the next one for you?
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