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MYLAN PHARMACEUTICALS Recalls
81 recalls on record · October 3, 2012 to August 5, 2026 · Drugs, Food & Beverage
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 24, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3 extended-cycle blister packs containing 91
Hazard: Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
September 19, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV
Hazard: Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
September 19, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV
Hazard: Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
August 15, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 mcg per spray, packaged in a 23
Hazard: Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
July 18, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc. M
Hazard: Subpotent Drug
June 20, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmac
Hazard: Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
May 30, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only, 48-count bottle, NDC 00378-4730-22
Hazard: CGMP Deviations
May 30, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22
Hazard: CGMP Deviations
May 30, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22
Hazard: CGMP Deviations
May 30, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01
Hazard: CGMP Deviations
May 30, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01
Hazard: CGMP Deviations
May 23, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV
Hazard: cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure
May 23, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV
Hazard: cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
January 31, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morganto
Hazard: Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to related out of specification compound results obtained during routine stability testing.
June 21, 2017DrugsFDA
Mylan Pharmaceuticals Inc. recalls Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
Hazard: Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
May 31, 2017DrugsFDA
Mylan Pharmaceuticals Inc. recalls Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack containing 21 tablets (NDC 0378-7
Hazard: Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
May 31, 2017DrugsFDA
Mylan Pharmaceuticals Inc. recalls Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 blister pack c
Hazard: Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
May 31, 2017DrugsFDA
Mylan Pharmaceuticals Inc. recalls Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Manufactured and Distributed by: Mylan Pharma
Hazard: Failed Dissolution Specifications
April 5, 2017DrugsFDA
Mylan Pharmaceuticals Inc. recalls Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC 0
Hazard: Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
April 5, 2017DrugsFDA
Mylan Pharmaceuticals Inc. recalls Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09) and b) 500-count bottles (NDC 0
Hazard: Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
April 5, 2017DrugsFDA
Mylan Pharmaceuticals Inc. recalls Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b) 500-count bottles (NDC 0
Hazard: Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
April 5, 2017DrugsFDA
Mylan Pharmaceuticals Inc. recalls Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-count bottles (NDC 0378-
Hazard: Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
March 15, 2017DrugsFDA
Mylan Pharmaceuticals Inc. recalls Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuticals Inc.,
Hazard: Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
March 8, 2017DrugsFDA
Mylan Pharmaceuticals Inc. recalls glipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- ND
Hazard: Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets
November 30, 2016DrugsFDA
Mylan Pharmaceuticals Inc. recalls Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-522
Hazard: Failed Impurities/Degradation Specifications: OOS results for known compound.
May 18, 2016DrugsFDA
Mylan Pharmaceuticals Inc. recalls Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --
Hazard: Failed Dissolution Specifications; three month stability time point.
July 15, 2015DrugsFDA
Mylan Pharmaceuticals Inc recalls Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378
Hazard: Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.
April 15, 2015DrugsFDA
Mylan Pharmaceuticals Inc. recalls Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy, Original Prescri
Hazard: Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
October 15, 2014DrugsFDA
Mylan Pharmaceuticals Inc. recalls Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mfg by Mylan Pharmaceuticals, Inc.
Hazard: Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol
September 3, 2014DrugsFDA
Mylan Pharmaceuticals Inc. recalls Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown
Hazard: Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.