CLASS II Drug recall · Reported 29 Jun 2022 · FDA Enforcement Report
Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches recalled
Mayne Pharma is recalling Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (, distributed nationwide in the US. The recall was initiated on 9 Jun 2022 and the FDA has classified it as Class II.
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-1152-2022
- FDA event ID
- 90406
- Recalling firm
- Mayne Pharma, Greenville, NC
- Brand
- Clonidine
- Manufacturer
- Mayne Pharma Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Jun 2022
- FDA classified
- 21 Jun 2022
- Reported
- 29 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 9 Jun 2022 | Recall initiated by company | |
| 21 Jun 2022 | Classified by FDA | +12 days |
| 29 Jun 2022 | 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
Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
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
Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton (51862-455-04), Rx only, Manufactured for: Mayne Pharma Greenville, NC 27834
Where it was distributed
Nationwide in the US Market
Questions about this recall
Why was it recalled?
Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
Which lots are affected?
Lot: 41179A Exp. Jan 2023
Where was it sold?
Nationwide in the US Market
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 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 Mayne Pharma
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lexette (halobetasol propionate) Topical Foam, 0.05% canisters recalled | Mayne Pharma | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Carbidopa and Levodopa Tablets, USP 25 mg/250mg recalled by Mayne Pharma | Mayne Pharma | Packaging Defects | Nationwide |
| Drug | CLASS III | Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg recalled | Mayne Pharma | Labeling Errors | Nationwide |
| Drug | CLASS III | Fabior (tazarotene) Foam recalled by Mayne PharmaFabior | Mayne Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Liothyronine Sodium Tablets, USP 25 mcg recalled by Mayne Pharma | Mayne Pharma | Potency & Assay | Nationwide |
Other Clonidine recalls
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clonidine Transdermal System, USP, 0.3 mg/day, supplied recalledClonidine Transdermal System | Teva Pharmaceuticals USA | Manufacturing (CGMP) Deviations | NJ |
| Drug | CLASS II | Clonidine Transdermal System, USP, 0.1 mg/day, supplied recalledClonidine Transdermal System | Teva Pharmaceuticals USA | Manufacturing (CGMP) Deviations | NJ |
| Drug | CLASS II | Clonidine Transdermal System, USP, 0.2 mg/day, supplied recalledClonidine Transdermal System | Teva Pharmaceuticals USA | Manufacturing (CGMP) Deviations | NJ |
| Drug | CLASS III | Clonidine Hydrochloride Tablets, USP, 0.3 mg recalledClonidine Hydrochloride | Unichem Pharmaceuticals USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Clonidine Hydrochloride Tablets, USP, 0.1 mg recalled | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |