FDAClass III · Drug · Recall D-0550-2026 · Recalled June 3, 2026

Nicotine Transdermal System Patch recall — AVEVA Drug Delivery Systems, Inc.

Agency report date: June 3, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Nicotine Transdermal System Patch
Company / brand: AVEVA Drug Delivery Systems
Lot / serial / date codes: Lot #: 56841, Expires: 03/2028
Distribution: Nationwide within the U.S

Agency product description and boundaries

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.

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class III: not likely to cause adverse health consequences.

Affected product: Nicotine Transdermal System Patch recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0550-2026
Brand: All AVEVA Drug Delivery Systems recalls
Classification: Class III
Units affected: 59,808 pouches (4,272 Individual Folding Carton (IFC))
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Nicotine Transdermal System Patch recall status

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

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Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved September 1, 2026 at 6:00 PM UTC.

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