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FDAClass III

Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGB… Recalled: Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impuri…

Nicotine Transdermal System Patch, 14 mg, 14 patches per… was recalled on May 14, 2026 in cooperation with the U.S. Food and Drug Administration because failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during…

Is my unit affected?

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.

Model, lot & date codes to check

Lot #: 56841, Expires: 03/2028

Units affected: 59,808 pouches (4,272 Individual Folding Carton (IFC))

Where it was sold: Nationwide within the U.S

Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.

What's the hazard?

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

Class III means the product is unlikely to cause a health problem, but it violates FDA labeling or manufacturing rules.

Your remedy & how to claim it

Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.

Contact: Recalling firm: AVEVA Drug Delivery Systems, Inc.

Not sure what you're entitled to? Read our guide: what to do if your product is recalled.

Official recall notice

Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.

View official notice →

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