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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.
August 5, 2026DrugsFDA
MYLAN PHARMACEUTICALS INC recalls Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: M
Hazard: Presence of precipitate
March 11, 2026DrugsFDA
MYLAN PHARMACEUTICALS INC recalls Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: My
Hazard: Failed Dissolution Specifications
March 26, 2025DrugsFDA
MYLAN PHARMACEUTICALS INC recalls Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 265
Hazard: Failed Dissolution Specifications - low dissolution results
August 3, 2022DrugsFDA
Mylan Pharmaceuticals Inc recalls Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packag
Hazard: Labeling: Missing label: Label missing from some prefilled pens.
May 4, 2022DrugsFDA
Mylan Pharmaceuticals Inc recalls Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multiple-Dose vial inside
Hazard: Labeling: Missing label on the vial
April 27, 2022DrugsFDA
Mylan Pharmaceuticals Inc recalls Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morga
Hazard: Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
April 13, 2022DrugsFDA
Mylan Pharmaceuticals Inc recalls Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morga
Hazard: Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance impurities/degradation during routine stability testing.
February 2, 2022DrugsFDA
Mylan Pharmaceuticals Inc recalls Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers, Rx O
Hazard: cGMP deficiencies
January 26, 2022DrugsFDA
Mylan Pharmaceuticals Inc recalls Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 m
Hazard: Labeling: Missing Label: label missing from some Semglee prefilled pens.
October 28, 2020DrugsFDA
Mylan Pharmaceuticals Inc. recalls Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002
Hazard: Out-of-specification organic impurity results obtained during routine stability testing.
April 1, 2020DrugsFDA
Mylan Pharmaceuticals Inc. recalls Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047
Hazard: Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
March 25, 2020DrugsFDA
Mylan Pharmaceuticals Inc. recalls Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. ND
Hazard: Presence of particulate matter. presence of metal particles.
January 29, 2020DrugsFDA
Mylan Pharmaceuticals Inc. recalls Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.
Hazard: CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
January 29, 2020DrugsFDA
Mylan Pharmaceuticals Inc. recalls Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.
Hazard: CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
November 13, 2019DrugsFDA
Mylan Pharmaceuticals Inc. recalls Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV
Hazard: Presence of Foreign Substance
November 6, 2019DrugsFDA
Mylan Pharmaceuticals Inc. recalls Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S
Hazard: Failed Dissolution Specification: Low out of specification dissolution results.
September 18, 2019DrugsFDA
Mylan Pharmaceuticals Inc. recalls Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV
Hazard: Failed Impurities/Degradation Specifications:OOS for unknown impurity.
February 27, 2019DrugsFDA
Mylan Pharmaceuticals Inc. recalls Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-coun
Hazard: Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
February 20, 2019Food & BeverageFDA
Mylan Pharmaceuticals Inc. recalls DrNatura Toxinout Kit Broad Spectrum Detoxification Program
Hazard: Mylan Consumer Healthcare has decided to initiate recall of the following products : Item# 46017-088-04 DrNatura Flora Protect Probiotics lot 3020068 Expiry Mar 2019 and Item# 46017-088-18 DrNatura Toxinout Kit lot 005983-001 Expiry Dec 2018 . The products are being recalled due to undeclared soy allergen statement.
February 20, 2019Food & BeverageFDA
Mylan Pharmaceuticals Inc. recalls DrNatura Flora Protect¿ Probiotics
Hazard: Mylan Consumer Healthcare has decided to initiate recall of the following products : Item# 46017-088-04 Dr Natura Flora Protect Probiotics lot 3020068 Expiry Mar 2019 . The products are being recalled due to undeclared soy allergen statement.
February 13, 2019DrugsFDA
Mylan Pharmaceuticals Inc. recalls Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays,
Hazard: Defective Container: Potential for broken glass in the neck area of the glass bottles.
February 6, 2019DrugsFDA
Mylan Pharmaceuticals Inc. recalls Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC
Hazard: Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
December 19, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Ph
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
December 19, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
December 19, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc.,
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
December 19, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., M
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
December 19, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc.,
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
December 19, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Valsartan Tablets, USP, 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc.,
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
December 19, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pha
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
December 19, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pha
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.