Nicotine Transdermal System Patch Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
AVEVA Drug Delivery Systems, Inc. is voluntarily recalling one lot of Nicotine Transdermal System Patch, 14 mg due to elevated oxidative-related impurities.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on June 23, 2026 and geographically references United States. Its severity classification of "low" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
AVEVA Drug Delivery Systems, Inc. initiated a voluntary recall of Nicotine Transdermal System Patch, 14 mg after stability testing found elevated levels of oxidative-related impurities exceeding shelf-life specifications.
Which Products Are Affected
Nicotine Transdermal System Patch, 14 mg, 14 patches per box, distributed by RUGBY LABORATORIES, NDC 0536-5895-88. Affected lot is 56841, expires 03/2028. A total of 59,808 pouches (4,272 Individual Folding Carton) are involved. Distribution was nationwide within the U.S.
What You Should Do
Consumers should stop using the affected product and contact the recalling firm or their pharmacy for return or refund instructions.
Why This Matters
The recall addresses a quality defect in a widely distributed over-the-counter nicotine replacement product sold nationwide.
Source
FDA recall D-0550-2026. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (948 characters here).
Similar severity timing
Same severity (low) notices issued closest in time to June 23, 2026.
Frequently Asked Questions
Common questions about this FDA recall.