Mayne Pharma Clonidine Transdermal System Recall: Defective Delivery System
Mayne Pharma recalls Clonidine Transdermal System 0.3 mg/day patches due to defective delivery system that may not release properly after 3 months.
Lower-risk recall
Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
Contact the company
What happened, in plain English
Mayne Pharma is recalling Clonidine Transdermal System patches because the delivery system may not release properly after 3 months. This could lead to incorrect medication levels if the patches fail to deliver the drug as intended. Read more at govinfonow.com/recall/34634-mayne-pharma-clonidine-transdermal-system-recall-defective-delivery-system.
Source Summary by GovInfoNow · govinfonow.com/recall/34634-mayne-pharma-clonidine-transdermal-system-recall-defective-delivery-system · Updated August 18, 2026 · FDA enforcement record: FDA #D-1152-2022
Cite this page
“Mayne Pharma Clonidine Transdermal System Recall: Defective Delivery System.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34634-mayne-pharma-clonidine-transdermal-system-recall-defective-delivery-system. Based on FDA recall #D-1152-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1152-2022%22&limit=1).
Why it’s dangerous
The delivery system may not release the medication properly after 3 months due to a defect in the release liner removal force. This could cause inconsistent drug delivery if the patches fail to function as intended.
Who’s affected
People with prescriptions for Clonidine Transdermal System 0.3 mg/day patches (NDC 51862-455-01) per carton (51862-455-04) manufactured in Greenville, NC. Those with the specific lot number 41179A (expiring Jan 2023) are most at risk.
How to tell if you have this one
Check for Clonidine Transdermal System 0.3 mg/day patches (NDC 51862-455-01) per carton (51862-455-04) with lot number 41179A, expiring January 2023, manufactured in Greenville, NC.
- Brand
Mayne Pharma- Category
Drug
What to do — step by step
Check Product Details
Verify the product's lot number and expiration date to confirm if it matches the recalled items.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the US Market” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The recall indicates a potential issue with the delivery system after 3 months, but the product is safe for use until the defect becomes a problem.
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Where this comes from
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-1152-2022 (June 9, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1152-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.