Mylan Pharmaceuticals Inc.: Recalls

84 recall records from Jun 28, 2012 to Aug 26, 2026, newest first. Showing 1 to 84.

What this list covers: FDA records filed under the name "Mylan Pharmaceuticals Inc." and its spelling variant "Mylan Pharmaceuticals".

Back to the Mylan Pharmaceuticals Inc. profile

NumberClassProductDate
D-0830-2026Class IICarton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials…Aug 26, 2026
D-0839-2026Class IIPrasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan…Aug 17, 2026
D-0774-2026Class IIAcamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan…Jul 24, 2026
D-0734-2026Class IIMycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only…Jul 2, 2026
D-0399-2026Class IIAmnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only…Feb 24, 2026
D-0280-2025Class IIPrasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals…Feb 25, 2025
D-1292-2022Class IInsulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC…Jul 5, 2022
D-0845-2022Class IInsulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL…Apr 12, 2022
D-0774-2022Class IIRifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan…Apr 7, 2022
D-0748-2022Class IITravoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan…Apr 1, 2022
D-0452-2022Class IIProctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g…Jan 21, 2022
D-0462-2022Class ISemglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71)…Jan 5, 2022
D-0049-2021Class IIICandesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count…Oct 2, 2020
D-1057-2020Class IIITacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV…Mar 23, 2020
D-1031-2020Class IISotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc…Mar 9, 2020
D-0792-2020Class IINizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.Jan 7, 2020
D-0791-2020Class IINizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.Jan 7, 2020
D-0186-2020Class IIAlprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals…Oct 23, 2019
D-0155-2020Class IIPrasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc…Oct 18, 2019
D-1848-2019Class IIIGatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals…Sep 6, 2019
D-0506-2019Class IIIDiltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC…Feb 13, 2019
D-0424-2019Class IIDymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray…Feb 1, 2019
D-0428-2019Class IIFexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b)…Jan 18, 2019
F-0859-2019Class IIDrNatura Toxinout Kit Broad Spectrum Detoxification ProgramDec 10, 2018
F-0858-2019Class IIDrNatura Flora Protect¿ ProbioticsDec 10, 2018
D-0318-2019Class IIAmlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India…Nov 20, 2018
D-0317-2019Class IIValsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in…Nov 20, 2018
D-0316-2019Class IIValsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan…Nov 20, 2018
D-0315-2019Class IIValsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan…Nov 20, 2018
D-0314-2019Class IIValsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan…Nov 20, 2018
D-0313-2019Class IIValsartan Tablets, USP, 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan…Nov 20, 2018
D-0312-2019Class IIAmlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India…Nov 20, 2018
D-0311-2019Class IIAmlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India…Nov 20, 2018
D-0025-2019Class IIILevonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3 extended-cycle blister…Aug 27, 2018
D-1187-2018Class IIIDiltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals…Aug 7, 2018
D-1186-2018Class IIIDiltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals…Aug 7, 2018
D-1075-2018Class IIDymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 mcg per…Jul 25, 2018
D-0978-2018Class IIITriamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan…Jul 9, 2018
D-0877-2018Class IIIMaxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx…Jun 7, 2018
D-0831-2018Class IIPrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only, 48-count bottle, NDC…Apr 30, 2018
D-0830-2018Class IIPrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC…Apr 30, 2018
D-0829-2018Class IIPrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC…Apr 30, 2018
D-0825-2018Class IILoxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01Apr 24, 2018
D-0824-2018Class IILoxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01Apr 24, 2018
D-0820-2018Class IIAmlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals…Apr 24, 2018
D-0819-2018Class IIAmlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals…Apr 24, 2018
D-0230-2018Class IIIbupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan…Nov 3, 2017
D-0920-2017Class IIIMontelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV…May 9, 2017
D-0621-2017Class IIAtorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b)…Mar 20, 2017
D-0620-2017Class IIAtorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09) and b)…Mar 20, 2017
D-0619-2017Class IIAtorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b)…Mar 20, 2017
D-0618-2017Class IIAtorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b)…Mar 20, 2017
D-0861-2017Class IIINorethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack containing 21…Jan 30, 2017
D-0860-2017Class IIITarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate…Jan 30, 2017
D-0492-2017Class IIMirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan…Jan 19, 2017
D-0491-2017Class IIglipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only, Mylan Pharmaceuticals Inc…Jan 19, 2017
D-0151-2017Class IIIDiltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count…Nov 3, 2016
D-0706-2017Class IIAlprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Manufactured and…Jun 22, 2016
D-0840-2016Class IIPaliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals…Feb 12, 2016
D-1217-2015Class IICapecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc…Jun 30, 2015
D-0435-2015Class IIIFexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies…Mar 11, 2015
D-0009-2015Class IIMetoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mfg by Mylan…Jul 3, 2014
D-1539-2014Class IIITolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc…Jun 20, 2014
D-1557-2014Class IIIDiltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan…Jun 19, 2014
D-1084-2014Class IILevothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by Mylan…Jan 14, 2014
D-66403-012Class IIAmlodipine Besylate Tablets, USP 10 mg, packaged in a) 90-count bottles (NDC 0378-5210-77) and b)…Sep 13, 2013
D-66403-011Class IICiprofloxacin Tablets, USP, 500 mg,100-count bottles, Rx only, Mylan Pharmaceuticals Inc…Sep 13, 2013
D-66403-010Class IIAmlodipine Besylate and Benazepril HCl Capsules, 10 mg/40 mg, 100-count bottles, Rx only, Mylan…Sep 13, 2013
D-66403-009Class IIAmlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg, in 100 count bottles (NDC# 0378-6898-01)…Sep 13, 2013
D-66403-008Class IIAmlodipine Besylate and Benazepril HCl Capsules, 5 mg/40 mg, 100-count bottles, Rx only, Mylan…Sep 13, 2013
D-66403-007Class IIAmlodipine Besylate and Benazepril HCl Capsules, 5 mg/20 mg, packaged in a) 100-count bottles (NDC…Sep 13, 2013
D-66403-006Class IIAmlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg, packaged in a) 100-count bottles (NDC…Sep 13, 2013
D-66403-005Class IIAmlodipine Besylate Tablets, USP, 5 mg, packaged in a) 90-count bottles (NDC 0378-5209-77) and b)…Sep 13, 2013
D-66403-004Class IICiprofloxacin Tablets, USP, 250 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc…Sep 13, 2013
D-66403-003Class IILamotrigine Tablets, USP, 200 mg, packaged in a) 60-count bottles (NDC 0378-4254-91) and b)…Sep 13, 2013
D-66403-002Class IIAmlodipine Besylate and Benazepril HCl Capsules, 2.5 mg/10 mg, 100-count bottles, Rx only, Mylan…Sep 13, 2013
D-66403-001Class IIAmlodipine Besylate Tablets, USP, 2.5 mg, packaged in a) 90-count bottles (NDC 0378-5208-77) and b)…Sep 13, 2013
D-500-2013Class IIRopinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx only…Apr 22, 2013
D-269-2013Class IIILisinopril Tablets, USP 10 mg, Rx only, 1000 count bottles, Manufactured for: Mylan Pharmaceuticals…Feb 26, 2013
D-147-2013Class IILansoprazole Delayed-release Capsules, USP, 30 mg, 500-count capsules per bottle, Rx only…Jan 30, 2013
D-137-2013Class IICarvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Mylan Pharmaceuticals Inc…Jan 16, 2013
D-033-2013Class IIDoxazosin Tablets, USP, 2 mg, 100 count bottles, labeled in part ***Manufactured in Australia by…Aug 7, 2012
D-1702-2012Class IILevetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan…Jul 27, 2012
D-1703-2012Class IIIFamotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown…Jun 28, 2012

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.