Severity
Low
LowClass IIIOngoing
FDA Drug recall · Reported June 3, 2026
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.
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
The recall
Aveva Drug Delivery Systems, Inc. issued this low-severity FDA Drug recall — Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shel….
- Low
- severity level
- Class III
- classification
- June 3, 2026
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0550-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0550-2026) was formally reported on June 3, 2026, with the manufacturer initiating the action on May 14, 2026. It is classified under Low severity (Class III), with a current status of Ongoing. Aveva Drug Delivery Systems, Inc. is listed as the recalling firm, operating out of Miramar, FL. Federal records list the affected scope as 59,808 pouches (4,272 Individual Folding Carton (IFC)).
The documented reason for this recall is: Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units. Distribution data in the federal record shows the product reached: Nationwide within the U.S. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category — 14,048 drugs & medications recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified low severity.
Affected scope
59,808 pouches (4,272 Individual Folding Carton (IFC))
Related Recalls
6
5 from same agency
Product 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.
Reason for recall
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Ongoing |
| Recall number | D-0550-2026 |
| Date reported | June 3, 2026 |
| Date initiated | May 14, 2026 |
| Recalling firm | Aveva Drug Delivery Systems, Inc. |
| Firm location | Miramar, FL |
| Affected scope | 59,808 pouches (4,272 Individual Folding Carton (IFC)) |
| Distribution | Nationwide within the U.S |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0550-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting — recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Aveva Drug Delivery Systems, Inc.. Units affected: 59,808 pouches (4,272 Individual Folding Carton (IFC)).
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 3, 2026. Severity: Low. Recall number: D-0550-2026.
Where was the recalled product distributed? ▼
Distribution: Nationwide within the U.S.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0550-2026) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Drug, reported June 3, 2026.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.