FDAClass III · Drug · Recalled June 3, 2026

Nicotine Transdermal System Patch recall — AVEVA Drug Delivery Systems, Inc.

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

Class III: not likely to cause adverse health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0550-2026
Brand: AVEVA Drug Delivery Systems
Classification: Class III
Units affected: 59,808 pouches (4,272 Individual Folding Carton (IFC))
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

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.

Affected products

Nicotine Transdermal System Patch

Companies & origin

Recalling firm location: Miramar, FL, United States
Firm address: 3250 Commerce Pkwy, 33025-3907

Identifying details (verbatim from the notice)

Product codes / lots: Lot #: 56841, Expires: 03/2028
Distribution: Nationwide within the U.S
Firm notified the public via: Letter
FDA event ID: 98972
Recall initiated: May 14, 2026
FDA classified: May 26, 2026
FDA report date: June 3, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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