FreshRecalls

⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a very recent recall may be missing. Everything shown is accurate as of the last checked time on this page — for anything time-critical, confirm with the official sources linked below.

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

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 23, 2026 at 11:04 PM UTC.

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