Mayne Pharma Inc
FDA Regulatory Profile
Mayne Pharma Inc has 6 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record.
- Latest recall
- D-1152-2022 · Class II · Jun 9, 2022
- Latest inspection
- Jul 17, 2025 · NAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 6 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 1 | Nov 10, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-1152-2022 | Class II | Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton… | Jun 9, 2022 |
| D-0387-2022 | Class II | Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne… | Jan 14, 2022 |
| D-0998-2020 | Class II | Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma, Greenville… | Mar 2, 2020 |
| D-1129-2018 | Class III | Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx Only, Manufactured by… | Aug 21, 2018 |
| D-0616-2018 | Class III | Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC… | Mar 21, 2018 |
| D-0098-2018 | Class II | Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distributed by Perrigo… | Nov 9, 2017 |
Recent FDA Inspections
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3016589167 | Raleigh, NC | 1 | Jul 17, 2025 |