“Aveva Nicotine Patch Recall: Impurities Risk During Use.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31307-aveva-nicotine-patch-recall-impurities-risk-during-use. Based on FDA recall #D-0550-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0550-2026%22&limit=1).
The FDA announced on May 14, 2026, that Aveva Drug Delivery Systems is voluntarily recalling Nicotine Transdermal System Patches due to elevated impurity levels. The recall affects approximately 59,808 pouches distributed nationwide.
How to tell if you have it
Brand: Aveva
Product: Nicotine Transdermal System Patch, 14 mg, 14 patches per box
Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268
NDC: 0536-5895-88
Lot #: 56841
Expires: 03/2028
The hazard
The recall is due to failed impurity specifications, specifically elevated levels of oxidative-related impurities that exceed shelf-life limits during stability testing. The FDA classified this as a Class III recall.
Context
GovInfoNow's records show AVEVA Drug Delivery Systems, Inc. has one other recall on record since February 15, 2023, involving buprenorphine patches with similar impurity issues. Other recent recalls of similar products include Teva Clonidine Transdermal System Recall (March 19, 2026), Novadoz Glycopyrrolate Oral Solution Recall (December 15, 2025), and Glenmark Alyacen Birth Control Tablets Recall (May 27, 2026). FDA's FAERS database contains 14,919 adverse-event reports naming this product across NDCs 0536-5894, 0536-5895, and 0536-5896, with 10,499 marked serious and 1,563 listing a death.
How to tell if you have this one
Check for the lot number 56841 on the patch box. The product expires March 2028 and is distributed by Rugby Laboratories in Indianapolis.
Brand
Aveva
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Patch Lot Number
Look for the lot number 56841 on the box to confirm if your patch is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide within the U.S” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 20 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Take action
Contact Aveva
We’ve drafted a message you can send Aveva to request your refund or repair — edit it as you like.
Subject: Recall D-0550-2026 — Aveva Nicotine Patch Recall: Impurities Risk During Use
Hello,
I own a Aveva Nicotine Patch Recall: Impurities Risk During Use that is covered by recall D-0550-2026 from Aveva.
I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?
Thank you.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0550-2026 (May 14, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0550-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.