Mylan Pharmaceuticals Inc.: 79 recalls on record

Recalls filed with 1 agency: FDA (79).

First recall on record: October 3, 2012. Most recent: September 9, 2026.

Risk classification: Class I: 3 · Class II: 59 · Class III: 17

Most recent recalls

DateAgencyProduct
September 9, 2026FDAPrasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan…D-0839-2026
September 9, 2026FDACarton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Do…D-0830-2026
August 26, 2026FDAAcamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan…D-0774-2026
August 5, 2026FDAMycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carto…D-0734-2026
March 11, 2026FDAAmnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs…D-0399-2026
March 26, 2025FDAPrasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceu…D-0280-2025
August 3, 2022FDAInsulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled …D-1292-2022
May 4, 2022FDAInsulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 1…D-0845-2022
April 27, 2022FDARifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for:…D-0774-2022
April 13, 2022FDATravoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: My…D-0748-2022
February 2, 2022FDAProctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol…D-0452-2022
January 26, 2022FDASemglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502…D-0462-2022
October 28, 2020FDACandesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) …D-0049-2021
April 1, 2020FDATacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morg…D-1057-2020
March 25, 2020FDASotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals In…D-1031-2020
January 29, 2020FDANizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.D-0792-2020
January 29, 2020FDANizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.D-0791-2020
November 6, 2019FDAPrasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceutical…D-0155-2020
September 18, 2019FDAGatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharm…D-1848-2019
February 27, 2019FDADiltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC…D-0506-2019
February 20, 2019FDADrNatura Toxinout Kit Broad Spectrum Detoxification ProgramF-0859-2019
February 20, 2019FDADrNatura Flora Protect¿ ProbioticsF-0858-2019
February 13, 2019FDADymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg…D-0424-2019
February 6, 2019FDAFexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93)…D-0428-2019
December 19, 2018FDAValsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manufactured for…D-0314-2019

Questions about this company

How many recalls does Mylan Pharmaceuticals Inc. have?
Recalert has 79 U.S. recalls on record for Mylan Pharmaceuticals Inc., published between October 3, 2012 and September 9, 2026.
What was the most recent Mylan Pharmaceuticals Inc. recall?
FDA recall D-0839-2026, published September 9, 2026: Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93.
Which agencies have handled Mylan Pharmaceuticals Inc. recalls?
Mylan Pharmaceuticals Inc. appears as the recalling firm in recalls from: FDA (79).

Do you carry products from Mylan Pharmaceuticals Inc.? Check your whole catalog free against 80,000+ recalls.

Paste up to 100 UPCs or SKUs and see which ones match a CPSC, FDA, NHTSA or FSIS recall. No account needed.

Check my catalog free

Want it checked every night instead? Starter watches 500 SKUs for $29/month. See plans

Related companies