CLASS III ONGOING Drug recall · Reported 3 Jun 2026 · FDA Enforcement Report
Nicotine Transdermal System Patch, 14 mg, 14 patches per, Aveva recalled
AVEVA Drug Delivery Systems is recalling Nicotine Transdermal System Patch, 14 mg, 14 patches per, Aveva, distributed nationwide in the US. The recall was initiated on 14 May 2026 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0550-2026
- FDA event ID
- 98972
- Recalling firm
- AVEVA Drug Delivery Systems, Miramar, FL
- Brand
- Nicotine
- Manufacturer
- Rugby Laboratories
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 14 May 2026
- FDA classified
- 26 May 2026
- Reported
- 3 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 14 May 2026 | Recall initiated by company | |
| 26 May 2026 | Classified by FDA | +12 days |
| 3 Jun 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide within the U.S
Questions about this recall
Is Nicotine Transdermal System Patch, 14 mg, 14 patches per, Aveva recalled?
Yes. AVEVA Drug Delivery Systems recalled Nicotine Transdermal System Patch, 14 mg, 14 patches per, Aveva on 14 May 2026. The recall is Class III and its status is Ongoing. Recall number D-0550-2026.
Why was it recalled?
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Which lots are affected?
Lot #: 56841, Expires: 03/2028
Where was it sold?
Nationwide within the U.S
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from AVEVA Drug Delivery Systems
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Buprenorphine Transdermal System, CIII 10 mcg/hour recalled | AVEVA Drug Delivery Systems | Potency & Assay | Nationwide |
| Drug | CLASS III | Buprenorphine Transdermal System, CIII 20 mcg/hour recalled | AVEVA Drug Delivery Systems | Potency & Assay | Nationwide |