Mylan LLC.
Complete recall history across all FDA and CPSC categories — 5 total recalls
Mylan LLC. 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 (5)
FDA drug safety enforcement actions by Mylan LLC.
| Date | Product | Reason | Class |
|---|---|---|---|
| Dec 20, 2016 | Temozolomide Capsules, 140 mg, packaged in a) 5-count bottles (NDC 0378-5263-... | Failed Tablet/Capsule Specifications: customer complaints of broken or crushe... | Class II |
| Dec 20, 2016 | Temozolomide Capsules, 180 mg, packaged in a) 5-count bottles (NDC 0378-5264-... | Failed Tablet/Capsule Specifications: customer complaints of broken or crushe... | Class II |
| Dec 20, 2016 | Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceutical... | Failed Tablet/Capsule Specifications: customer complaints of broken or crushe... | Class II |
| Dec 20, 2016 | Temozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-... | Failed Tablet/Capsule Specifications: customer complaints of broken or crushe... | Class II |
| Jun 29, 2012 | Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceu... | Failed USP Content Uniformity Requirements: OOS result reported on retained s... | 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.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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