Mylan Pharmaceuticals recalls

Mylan Pharmaceuticals has 83 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 9 Sep 2026. 13 are still ongoing. 4 were reported in the last 12 months. The most frequent reason is potency & assay.

Total recalls83since 2012

Last 12 months4reported

Class I34% of total

Ongoing13latest 9 Sep 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 1 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 1 0Apr 0 0 0Jul 2 1

Severity split

Class I 3 4%Class II 61 73%Class III 19 23%

Why mylan pharmaceuticals is recalled

Product types

Brands

Valsartan45%
Atorvastatin Calcium45%
Amlodipine And Valsartan34%
Dymista22%
Prasugrel22%
Mycophenolate Mofetil22%
Tacrolimus11%
Candesartan Cilexetil And Hydrochlorothiazide11%

By year

202645%
202511%
202267%
202056%
2019810%
20182227%
20171012%
201622%
201522%
201445%

Ongoing mylan pharmaceuticals recalls

13 active

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Carton label: Mycophenolate Mofetil for injection recalledMycophenolate Mofetil	Mylan Pharmaceuticals	Sterility	Nationwide
26 Aug 2026Drug	CLASS II	Acamprosate Calcium, Delayed-Release Tablets, 333 mg recalledAcamprosate Calcium	Mylan Pharmaceuticals	Potency & Assay	Nationwide
5 Aug 2026Drug	CLASS II	Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate Mofetil	Mylan Pharmaceuticals	Other	Nationwide
11 Mar 2026Drug	CLASS II	Amnesteem (Isotretinoin) Capsules, USP 40 mg recalledAmnesteem	Mylan Pharmaceuticals	Potency & Assay	Nationwide
26 Mar 2025Drug	CLASS II	Prasugrel Tablets, USP, 5 mg recalled by Mylan PharmaceuticalsPrasugrel	Mylan Pharmaceuticals	Potency & Assay	Nationwide
19 Dec 2018Drug	CLASS II	Valsartan Tablets, USP, 80 mg recalled by Mylan PharmaceuticalsValsartan	Mylan Pharmaceuticals	Nitrosamine Impurity	Nationwide

All mylan pharmaceuticals recalls, newest first

83 total

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Carton label: Mycophenolate Mofetil for injection recalledMycophenolate Mofetil	Mylan Pharmaceuticals	Sterility	Nationwide
26 Aug 2026Drug	CLASS II	Acamprosate Calcium, Delayed-Release Tablets, 333 mg recalledAcamprosate Calcium	Mylan Pharmaceuticals	Potency & Assay	Nationwide
5 Aug 2026Drug	CLASS II	Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate Mofetil	Mylan Pharmaceuticals	Other	Nationwide
11 Mar 2026Drug	CLASS II	Amnesteem (Isotretinoin) Capsules, USP 40 mg recalledAmnesteem	Mylan Pharmaceuticals	Potency & Assay	Nationwide
26 Mar 2025Drug	CLASS II	Prasugrel Tablets, USP, 5 mg recalled by Mylan PharmaceuticalsPrasugrel	Mylan Pharmaceuticals	Potency & Assay	Nationwide
3 Aug 2022Drug	CLASS I	Insulin Glargine (Insulin glargine-yfgn) Injection/mL recalled	Mylan Pharmaceuticals	Labeling Errors	Nationwide
4 May 2022Drug	CLASS I	Insulin Glargine (insulin glargine-yfgn) Injection/mL (U-100) recalled	Mylan Pharmaceuticals	Labeling Errors	Nationwide
27 Apr 2022Drug	CLASS II	Rifampin for Injection, USP, 600 mg/vial, One Vial recalledRifampin	Mylan Pharmaceuticals	Potency & Assay	Nationwide
13 Apr 2022Drug	CLASS II	Travoprost Ophthalmic Solution recalled by Mylan PharmaceuticalsTravoprost Ophthalmic Solution, 0.004%	Mylan Pharmaceuticals	Potency & Assay	Nationwide
2 Feb 2022Drug	CLASS II	Proctofoam HC (hydrocortisone acetate recalled by Mylan PharmaceuticalsProctofoam	Mylan Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.