Mylan Pharmaceuticals recalls
FDA enforcement reports naming Mylan Pharmaceuticals Inc as the recalling firm.
- Recall reports
- 72
- Class I (serious)
- 3
- Most recent report
- Sep 9, 2026
- Sep 9, 2026Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Myl…Drug · Mylan Pharmaceuticals IncFailed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteriaClass II
- Sep 9, 2026Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single…Drug · Mylan Pharmaceuticals IncFailed Dissolution SpecificationsClass II
- Aug 26, 2026Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Myl…Drug · Mylan Pharmaceuticals IncFailed Dissolution SpecificationsClass II
- Aug 5, 2026Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per car…Drug · MYLAN PHARMACEUTICALS INCPresence of precipitateClass II
- Mar 11, 2026Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Pac…Drug · MYLAN PHARMACEUTICALS INCFailed Dissolution SpecificationsClass II
- Mar 26, 2025Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmac…Drug · MYLAN PHARMACEUTICALS INCFailed Dissolution Specifications - low dissolution resultsClass II
- Aug 3, 2022Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefille…Drug · Mylan Pharmaceuticals IncLabeling: Missing label: Label missing from some prefilled pens.Class I
- May 4, 2022Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a…Drug · Mylan Pharmaceuticals IncLabeling: Missing label on the vialClass I
- Apr 27, 2022Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured fo…Drug · Mylan Pharmaceuticals IncFailed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.Class II
- Apr 13, 2022Travoprost Ophthalmic Solution, USP, 0Drug · Mylan Pharmaceuticals IncSubpotent 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 stab…Class II
- Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aeros…
- Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 495…
- Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12
- Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc
- Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc
- Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc
- Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc
- Alprazolam Tablets, USP 0
- Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceutic…
- Gatifloxacin Ophthalmic Solution 0
- Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (N…
- DrNatura Toxinout Kit Broad Spectrum Detoxification Program
- DrNatura Flora Protect¿ Probiotics
- Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 m…
- Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-9…
- Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manufactured f…
- Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in…
- Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx…
- Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in I…
- Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in I…
- Valsartan Tablets, USP, 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured f…
- Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manufactured f…
- Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manufactured fo…
- Levonorgestrel and Ethinyl Estradiol Tablets, USP 0
- Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Ph…
- Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Ph…
- Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50…
- Triamterene and Hydrochlorothiazide Tablets, USP 37
- Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37
- Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles
- Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles
- PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bo…
- PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count b…
- PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only, 48-count…
- Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharm…
- Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharm…
- bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, My…
- Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc
- Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Manufactured…
- Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0
- Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fu…
- Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09…
- Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09…
- Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09…
- Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77)
- Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx…
- glipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only, Mylan Pharmaceut…
- Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01…
- Paliperidone Extended-release Tablets, 1
- Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc
- Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allerg…
- Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mf…
- Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan…
- Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only
- Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by M…
- Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx onl…
- Lisinopril Tablets, USP 10 mg, Rx only, 1000 count bottles, Manufactured for: Mylan Ph…
- Lansoprazole Delayed-release Capsules, USP, 30 mg, 500-count capsules per bottle, Rx on…
- Carvedilol Tablets, USP, 12
- Doxazosin Tablets, USP, 2 mg, 100 count bottles, labeled in part ***Manufactured in Aus…
- Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc
- Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan P…
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