Mayne Pharma Inc
Complete recall history across all FDA and CPSC categories — 6 total recalls
Mayne Pharma Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (6)
FDA drug safety enforcement actions by Mayne Pharma Inc
| Date | Product | Reason | Class |
|---|---|---|---|
| Jun 9, 2022 | Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) pe... | Defective Delivery System: Out of specification for release liner removal fo... | Class II |
| Jan 14, 2022 | Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY,... | CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid ... | Class II |
| Mar 2, 2020 | Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayn... | Product Mix-Up: A foreign tablet was found in bottle. | Class II |
| Aug 21, 2018 | Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx ... | Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled... | Class III |
| Mar 21, 2018 | Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne... | Superpotent Drug: High out of specification results for tazarotene assay at t... | Class III |
| Nov 9, 2017 | Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distrib... | Failed Dissolution Specifications. | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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