May 2026 FDA Recall Nicotine by Aveva Drug Delivery Systems, Inc.
D-0550-2026 - Failed Impurities/Degradation Specifications
This Class III drug recall was voluntarily initiated by Aveva Drug Delivery Systems, Inc. on May 14, 2026 for the product Nicotine. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0550-2026
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
05-14-2026
06-03-2026
59,808 pouches (4,272 Individual Folding Carton (IFC))
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
AVEVA Drug Delivery Systems, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the U.S
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
Batch or Lot Expiration Information
Lot# : 56841, Expires: 03/2028
