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Mylan Pharmaceuticals Inc. Recalls

80 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Mylan Pharmaceuticals Inc..

80Total Recalls
3Critical
5.6MUnits Affected
Feb 24, 2026Most Recent
All Recalls

Every Mylan Pharmaceuticals Inc. Recall

Sorted by most recent. Click any recall for full details.

80 recalls
High RiskFDA
Mylan Pharmaceuticals Inc
Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceutica...
Oral Drugs·34,850 affected·Feb 24, 2026
High RiskFDA
Mylan Pharmaceuticals Inc
Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 03...
Oral Drugs·0 affected·Feb 25, 2025
CriticalFDA
Mylan Pharmaceuticals Inc
Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in cartons of ...
Injectable Drugs·253,200 affected·Jul 5, 2022
CriticalFDA
Mylan Pharmaceuticals Inc
Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multiple-Dose vial inside a carton, Rx only...
Injectable Drugs·89,665 affected·Apr 12, 2022
High RiskFDA
Mylan Pharmaceuticals Inc
Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 ...
Injectable Drugs·33,893 affected·Apr 7, 2022
High RiskFDA
Mylan Pharmaceuticals Inc
Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, ...
Ophthalmic Drugs·20,112 affected·Apr 1, 2022
High RiskFDA
Mylan Pharmaceuticals Inc
Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers, Rx Only, Distributed ...
Topical Drugs·233,199 affected·Jan 21, 2022
CriticalFDA
Mylan Pharmaceuticals Inc
Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 mL Prefilled Pens ...
Injectable Drugs·73,175 affected·Jan 5, 2022
RecallFDA
Mylan Pharmaceuticals Inc.
Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and b) 500-c...
Oral Drugs·10,695 affected·Oct 2, 2020
RecallFDA
Mylan Pharmaceuticals Inc.
Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047-01
Oral Drugs·3,816 affected·Mar 23, 2020
High RiskFDA
Mylan Pharmaceuticals Inc.
Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01
Oral Drugs·300 affected·Mar 9, 2020
High RiskFDA
Mylan Pharmaceuticals Inc.
Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.
Oral Drugs·31,736 affected·Jan 7, 2020
High RiskFDA
Mylan Pharmaceuticals Inc.
Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.
Oral Drugs·16,944 affected·Jan 7, 2020
High RiskFDA
Mylan Pharmaceuticals Inc.
Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Made in Aus...
Oral Drugs·5,760 affected·Oct 23, 2019
High RiskFDA
Mylan Pharmaceuticals Inc.
Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93
Oral Drugs·4,272 affected·Oct 18, 2019
RecallFDA
Mylan Pharmaceuticals Inc.
Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. Made in I...
Ophthalmic Drugs·13,157 affected·Sep 6, 2019
RecallFDA
Mylan Pharmaceuticals Inc.
Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 03...
Oral Drugs·8,159 affected·Feb 13, 2019
High RiskFDA
Mylan Pharmaceuticals Inc.
Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays, 23 g net fill we...
Inhaled / Nasal Drugs·10,390 affected·Feb 1, 2019
High RiskFDA
Mylan Pharmaceuticals Inc.
Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC 0378-0782-05); Ma...
Oral Drugs·88,090 affected·Jan 18, 2019
High RiskFDA
Mylan Pharmaceuticals Inc.
DrNatura Toxinout Kit Broad Spectrum Detoxification Program
Food·800 affected·Dec 10, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
DrNatura Flora Protect¿ Probiotics
Food·2,378 affected·Dec 10, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc...
Oral Drugs·12,336 affected·Nov 20, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, In...
Oral Drugs·48,302 affected·Nov 20, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc...
Oral Drugs·23,478 affected·Nov 20, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26...
Oral Drugs·25,147 affected·Nov 20, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 265...
Oral Drugs·63,213 affected·Nov 20, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26...
Oral Drugs·12,840 affected·Nov 20, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharm...
Oral Drugs·5,660 affected·Nov 20, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
Valsartan Tablets, USP, 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26...
Oral Drugs·24,709 affected·Nov 20, 2018
RecallFDA
Mylan Pharmaceuticals Inc.
Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3 extended-cycle blister packs containing 91 tablets each, Ma...
Oral Drugs·5,790 affected·Aug 27, 2018
RecallFDA
Mylan Pharmaceuticals Inc.
Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-...
Oral Drugs·11,799 affected·Aug 7, 2018
RecallFDA
Mylan Pharmaceuticals Inc.
Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-...
Oral Drugs·656 affected·Aug 7, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 mcg per spray, packaged in a 23 g net fill weight...
Inhaled / Nasal Drugs·20,780 affected·Jul 25, 2018
RecallFDA
Mylan Pharmaceuticals Inc.
Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc. Morgantown, WV 265...
Oral Drugs·28,436 affected·Jul 9, 2018
RecallFDA
Mylan Pharmaceuticals Inc.
Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Mo...
Oral Drugs·1,620 affected·Jun 7, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22
Oral Drugs·9,906 affected·Apr 30, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22
Oral Drugs·7,334 affected·Apr 30, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only, 48-count bottle, NDC 00378-4730-22
Oral Drugs·3,844 affected·Apr 30, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01
Oral Drugs·12,924 affected·Apr 24, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01
Oral Drugs·25,488 affected·Apr 24, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01
Oral Drugs·11,650 affected·Apr 24, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01
Oral Drugs·8,679 affected·Apr 24, 2018
RecallFDA
Mylan Pharmaceuticals Inc.
bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S....
Oral Drugs·1,414 affected·Nov 3, 2017
RecallFDA
Mylan Pharmaceuticals Inc.
Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
Oral Drugs·11,624 affected·May 9, 2017
High RiskFDA
Mylan Pharmaceuticals Inc.
Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-count bottles (NDC 0378-3950-09); c) 500-...
Oral Drugs·1,233,107 affected·Mar 20, 2017
High RiskFDA
Mylan Pharmaceuticals Inc.
Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09) and b) 500-count bottles (NDC 0378-3952-07); Rx ...
Oral Drugs·444,201 affected·Mar 20, 2017
High RiskFDA
Mylan Pharmaceuticals Inc.
Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b) 500-count bottles (NDC 0378-3951-07); Rx ...
Oral Drugs·299,112 affected·Mar 20, 2017
High RiskFDA
Mylan Pharmaceuticals Inc.
Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC 0378-3953-07), Rx ...
Oral Drugs·452,269 affected·Mar 20, 2017