Mylan Pharmaceuticals recalls

Mylan Pharmaceuticals has 84 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 9 Sep 2026. 14 are still ongoing. 5 were reported in the last 12 months. The most frequent reason is potency & assay.

Total recalls84since 2012

Last 12 months5reported

Class I34% of total

Ongoing14latest 9 Sep 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 1 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 1 0 0May 0 0 2Aug 2 0

Severity split

Class I 3 4%Class II 62 74%Class III 19 23%

Why mylan pharmaceuticals is recalled

Product types

Brands

Atorvastatin Calcium45%
Prasugrel34%
Amlodipine And Valsartan34%
Dymista22%
Mycophenolate Mofetil22%
Norethindrone Acetate And Ethinyl Estradiol11%
Mirtazapine11%
Acamprosate Calcium11%

By year

202656%
202511%
202267%
202056%
2019810%
20182226%
20171012%
201622%
201522%
201445%

Ongoing mylan pharmaceuticals recalls

14 active

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Prasugrel Tablets, USP, 10mg recalled by Mylan PharmaceuticalsPrasugrel	Mylan Pharmaceuticals	Potency & Assay	Nationwide
9 Sep 2026Drug	CLASS II	Carton label: Mycophenolate Mofetil for injection recalledMycophenolate Mofetil	Mylan Pharmaceuticals	Potency & Assay	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

All mylan pharmaceuticals recalls, newest first

84 total

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Prasugrel Tablets, USP, 10mg recalled by Mylan PharmaceuticalsPrasugrel	Mylan Pharmaceuticals	Potency & Assay	Nationwide
9 Sep 2026Drug	CLASS II	Carton label: Mycophenolate Mofetil for injection recalledMycophenolate Mofetil	Mylan Pharmaceuticals	Potency & Assay	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
26 Jan 2022Drug	CLASS I	Semglee (insulin glargine) injection/mL (U-100) Prefilled Pen recalled	Mylan Pharmaceuticals	Labeling Errors	Nationwide
28 Oct 2020Drug	CLASS III	Candesartan Cilexetil and Hydrochlorothiazide Tablets recalledCandesartan Cilexetil And Hydrochlorothiazide	Mylan Pharmaceuticals	Potency & Assay	Nationwide
1 Apr 2020Drug	CLASS III	Tacrolimus Capsules, USP 5mg recalled by Mylan PharmaceuticalsTacrolimus	Mylan Pharmaceuticals	Other	Nationwide
25 Mar 2020Drug	CLASS II	Sotalol HCL Tablets, USP (AF) 80 mg recalled by Mylan Pharmaceuticals	Mylan Pharmaceuticals	Particulate Matter	Nationwide
29 Jan 2020Drug	CLASS II	Nizatidine Capsules, USP 300 mg recalled by Mylan Pharmaceuticals	Mylan Pharmaceuticals	Nitrosamine Impurity	Nationwide
29 Jan 2020Drug	CLASS II	Nizatidine Capsules, USP 150 mg recalled by Mylan Pharmaceuticals	Mylan Pharmaceuticals	Nitrosamine Impurity	Nationwide
13 Nov 2019Drug	CLASS II	Alprazolam Tablets, USP 0.5 mg recalled by Mylan Pharmaceuticals	Mylan Pharmaceuticals	Other	Nationwide
6 Nov 2019Drug	CLASS II	Prasugrel Tablets 5 mg recalled by Mylan PharmaceuticalsPrasugrel	Mylan Pharmaceuticals	Potency & Assay	Nationwide
18 Sep 2019Drug	CLASS III	Gatifloxacin Ophthalmic Solution recalled by Mylan Pharmaceuticals	Mylan Pharmaceuticals	Potency & Assay	Nationwide
27 Feb 2019Drug	CLASS III	Diltiazem HCl Extended-Release Capsules, USP 180mg recalled	Mylan Pharmaceuticals	Potency & Assay	Nationwide
20 Feb 2019Food	CLASS II	DrNatura Flora Protect¿ Probiotics recalled by Mylan PharmaceuticalsDrNatura Flora	Mylan Pharmaceuticals	Undeclared Soy	WV
20 Feb 2019Food	CLASS II	DrNatura Toxinout Kit Broad Spectrum Detoxification Program recalledDrNatura Toxinout	Mylan Pharmaceuticals	Undeclared Soy	WV
13 Feb 2019Drug	CLASS II	Dymista (azelastine hydrochloride recalled by Mylan PharmaceuticalsDymista	Mylan Pharmaceuticals	Foreign Material	Nationwide
6 Feb 2019Drug	CLASS II	Fexofenadine HCl Tablets, USP, 180 mg recalled by Mylan Pharmaceuticals	Mylan Pharmaceuticals	Potency & Assay	Nationwide
19 Dec 2018Drug	CLASS II	Valsartan Tablets, USP, 80 mg recalled by Mylan Pharmaceuticals	Mylan Pharmaceuticals	Nitrosamine Impurity	Nationwide
19 Dec 2018Drug	CLASS II	Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) recalledValsartan And Hydrochlorothiazide	Mylan Pharmaceuticals	Nitrosamine Impurity	Nationwide
19 Dec 2018Drug	CLASS II	Valsartan Tablets, USP, 160 mg recalled by Mylan Pharmaceuticals	Mylan Pharmaceuticals	Nitrosamine Impurity	Nationwide
19 Dec 2018Drug	CLASS II	Valsartan Tablets, USP, 40 mg recalled by Mylan Pharmaceuticals	Mylan Pharmaceuticals	Nitrosamine Impurity	Nationwide
19 Dec 2018Drug	CLASS II	Valsartan Tablets, USP, 320 mg recalled by Mylan Pharmaceuticals	Mylan Pharmaceuticals	Nitrosamine Impurity	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.