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Class III · Lower riskActive recall

Nicotine

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: 56841, Expires: 03/2028
Where it was soldNationwide within the U.S
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byRugby Laboratories
Brand nameNICOTINE
Generic nameNICOTINE
Active ingredient(s)NICOTINE
Distributed by / forRUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com
NDC0536-5895-88
Show the full FDA record
Full product labelNicotine 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 firmAVEVA Drug Delivery Systems, Inc.
DistributionNationwide within the U.S
Quantity59,808 pouches (4,272 Individual Folding Carton (IFC))
Recall initiated2026-05-14
Report date2026-06-03
Recall completed—
Recall numberD-0550-2026
ClassificationClass III
FDA statusOngoing
Origin on fileMiramar FL United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.