Mylan Pharmaceuticals Inc.
Complete recall history across all FDA and CPSC categories — 71 total recalls
Recall Summary
Mylan Pharmaceuticals Inc. appears in recall records across 2 categories. 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.
Food Recalls (2)
FDA food safety enforcement actions by Mylan Pharmaceuticals Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Dec 10, 2018 | DrNatura Flora Protect¿ Probiotics | Mylan Consumer Healthcare has decided to initiate recall of the following pro... | Class II |
| Dec 10, 2018 | DrNatura Toxinout Kit Broad Spectrum Detoxification Program | Mylan Consumer Healthcare has decided to initiate recall of the following pro... | Class II |
Drug Recalls (69)
FDA drug safety enforcement actions by Mylan Pharmaceuticals Inc.. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Oct 2, 2020 | Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, pac... | Out-of-specification organic impurity results obtained during routine stabili... | Class III |
| Mar 23, 2020 | Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceutical... | Presence of foreign tablet/capsule - Potential presence of commingled one Tac... | Class III |
| Mar 9, 2020 | Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharma... | Presence of particulate matter. presence of metal particles. | Class II |
| Jan 7, 2020 | Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 037... | CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) ... | Class II |
| Jan 7, 2020 | Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 037... | CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) ... | Class II |
| Oct 23, 2019 | Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for:... | Presence of Foreign Substance | Class II |
| Oct 18, 2019 | Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Ph... | Failed Dissolution Specification: Low out of specification dissolution results. | Class II |
| Sep 6, 2019 | Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: ... | Failed Impurities/Degradation Specifications:OOS for unknown impurity. | Class III |
| Feb 13, 2019 | Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count ... | Failed Impurities/Degradation Specifications: High out of specification resul... | Class III |
| Feb 1, 2019 | Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 13... | Defective Container: Potential for broken glass in the neck area of the glass... | Class II |
| Jan 18, 2019 | Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0... | Failed Impurities/Degradation Specifications: Related compound results obtain... | Class II |
| Nov 20, 2018 | Valsartan Tablets, USP, 80 mg, 90-count bottles, Rx Only, Made in India, Manu... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamin... | Class II |
| Nov 20, 2018 | Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count b... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamin... | Class II |
| Nov 20, 2018 | Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manu... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamin... | Class II |
| Nov 20, 2018 | Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manuf... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamin... | Class II |
| Nov 20, 2018 | Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manu... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamin... | Class II |
| Nov 20, 2018 | Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only,... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamin... | Class II |
| Nov 20, 2018 | Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamin... | Class II |
| Nov 20, 2018 | Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only,... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamin... | Class II |
| Aug 27, 2018 | Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3... | Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified ... | Class III |
| Aug 7, 2018 | Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only... | Failed Impurities/Degradation Specifications: Out of specification test resul... | Class III |
| Aug 7, 2018 | Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only... | Failed Impurities/Degradation Specifications: Out of specification test resul... | Class III |
| Jul 25, 2018 | Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 13... | Presence of foreign substance: Potential for glass in the neck area of the gl... | Class II |
| Jul 9, 2018 | Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bot... | Subpotent Drug | Class III |
| Jun 7, 2018 | Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 m... | Superpotent Drug: Composite assay results obtained during routine stability t... | Class III |
| Apr 30, 2018 | PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only,... | CGMP Deviations | Class II |
| Apr 30, 2018 | PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 4... | CGMP Deviations | Class II |
| Apr 30, 2018 | PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, ... | CGMP Deviations | Class II |
| Apr 24, 2018 | Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01 | CGMP Deviations | Class II |
| Apr 24, 2018 | Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01 | CGMP Deviations | Class II |
| Apr 24, 2018 | Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, M... | cGMP Deviations; cleaning process for equipment used to manufacture the speci... | Class II |
| Apr 24, 2018 | Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, M... | cGMP Deviations; cleaning processes for equipment used to manufacture the spe... | Class II |
| Nov 3, 2017 | bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, R... | Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is c... | Class III |
| May 9, 2017 | Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals ... | Failed Impurities/Degradation Specifications; out of specification results fo... | Class III |
| Mar 20, 2017 | Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 03... | Microbial Contamination of Non-Sterile Products: potential of an elevated bio... | Class II |
| Mar 20, 2017 | Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 03... | Microbial Contamination of Non-Sterile Products: potential of an elevated bio... | Class II |
| Mar 20, 2017 | Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 03... | Microbial Contamination of Non-Sterile Products: potential of an elevated bio... | Class II |
| Mar 20, 2017 | Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 03... | Microbial Contamination of Non-Sterile Products: potential of an elevated bio... | Class II |
| Jan 30, 2017 | Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and ... | Chemical Contamination: out of specification results for impurities were foun... | Class III |
| Jan 30, 2017 | Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 bli... | Chemical Contamination: out of specification results for impurities were foun... | Class III |
| Jan 19, 2017 | glipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only, Mylan ... | Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may c... | Class II |
| Jan 19, 2017 | Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bo... | Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet i... | Class II |
| Nov 3, 2016 | Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 03... | Failed Impurities/Degradation Specifications: OOS results for known compound. | Class III |
| Jun 22, 2016 | Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Ma... | Failed Dissolution Specifications | Class II |
| Feb 12, 2016 | Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Myl... | Failed Dissolution Specifications; three month stability time point. | Class II |
| Mar 11, 2015 | Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outd... | Failed Impurities/Degradation Specifications: out of specification results fo... | Class III |
| Jul 3, 2014 | Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, R... | Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of... | Class II |
| Jun 20, 2014 | Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharma... | Failed Impurities/Degradation Specifications; Out of specification for lactol... | Class III |
| Jun 19, 2014 | Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx on... | Failed Impurities/Degradation Specifications: High out-of-specification resul... | Class III |
| Jan 14, 2014 | Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distri... | Subpotent Drug: Assay results obtained during stability testing for Levothyro... | 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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