The Recall Desk

Manufacturer

Mylan Pharmaceuticals Inc.

82 recalls in our database name Mylan Pharmaceuticals Inc. as the manufacturing or recalling firm.

What the numbers show

Total
82
Critical
2
Severe
30
Most recent
2026-08-26

Of the 82 recalls from Mylan Pharmaceuticals Inc. we have scored against our rubric, 2 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 30 (37%) are Severe.

Which agencies issued them

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–50 of 82

  • SevereFDA (Drugs)·D-0315-2019·2018-12-19

    Mylan Recalls Valsartan Tablets Due to NDEA Impurity

    Mylan Pharmaceuticals is recalling Valsartan 40 mg tablets because FDA labs confirmed the presence of the impurity N-nitrosodiethylamine (NDEA).

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0312-2019·2018-12-19

    Mylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Mylan Pharmaceuticals is recalling Amlodipine and Valsartan tablets because FDA testing confirmed the presence of the impurity N-nitrosodiethylamine (NDEA).

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0318-2019·2018-12-19

    Mylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Mylan Pharmaceuticals is recalling Amlodipine and Valsartan tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA) in the active ingredient.

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0314-2019·2018-12-19

    Mylan Recalls Valsartan Tablets Due to NDEA Impurity

    Mylan Pharmaceuticals is recalling Valsartan tablets because FDA labs confirmed the presence of the impurity N-nitrosodiethylamine (NDEA). The affected product was distributed throughout the United States.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0311-2019·2018-12-19

    Mylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Mylan Pharmaceuticals is recalling Amlodipine and Valsartan tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA) in the active ingredient.

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0313-2019·2018-12-19

    Mylan Recalls Valsartan Tablets Due to NDEA Impurity

    Mylan Pharmaceuticals is recalling Valsartan tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA). The affected product was distributed throughout the United States.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0025-2019·2018-10-24

    Mylan Recalls Levonorgestrel and Ethinyl Estradiol Tablets Due to Labeling Errors

    Mylan Pharmaceuticals is recalling specific lots of levonorgestrel and ethinyl estradiol tablets because the blister packs display incorrect NDC and product name information.

    Product
    Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3 extended-cycle blister packs containing 91 tablets each, Made in India, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7281-53.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1186-2018·2018-09-19

    Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

    Mylan Pharmaceuticals is recalling Diltiazem HCl Extended-Release Capsules 120 mg because routine stability testing revealed out-of-specification results for related compounds.

    Product
    Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1187-2018·2018-09-19

    Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

    Mylan Pharmaceuticals is recalling 656 bottles of Diltiazem HCl Extended-Release Capsules 120 mg because routine stability testing found out-of-specification related compounds.

    Product
    Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1075-2018·2018-08-15

    Mylan Recalls Dymista Nasal Spray Due to Potential Glass Contamination

    Mylan Pharmaceuticals is recalling 20,780 bottles of Dymista nasal spray because glass fragments may be present in the neck area of the bottles.

    Product
    DYMISTA — DYMISTA (AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0978-2018·2018-07-18

    Mylan Recalls Subpotent Triamterene and Hydrochlorothiazide Tablets Nationwide

    Mylan Pharmaceuticals is voluntarily recalling 28,436 bottles of Triamterene and Hydrochlorothiazide Tablets because the medication was found to be subpotent.

    Product
    Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc. Morgantown, WV 26505, NDC 0378-1352-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0877-2018·2018-06-20

    Mylan Recalls Maxzide-25 Tablets Due to Slightly High Potency

    Mylan Pharmaceuticals is recalling 1,620 bottles of Maxzide-25 tablets because routine stability testing showed potency slightly above specification.

    Product
    Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-0464-01
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0825-2018·2018-05-30

    Mylan Recalls Loxapine Capsules Due to Manufacturing Deviations

    Mylan Pharmaceuticals is voluntarily recalling 11,650 bottles of Loxapine Capsules 50 mg due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0824-2018·2018-05-30

    Mylan Recalls Loxapine Capsules Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling 8,679 bottles of Loxapine Capsules 25 mg due to CGMP deviations. The product was distributed throughout the United States and Puerto Rico.

    Product
    Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0829-2018·2018-05-30

    Mylan Recalls Prednisolone Sodium Phosphate Tablets Due to Manufacturing Deviations

    Mylan Pharmaceuticals is voluntarily recalling specific lots of Prednisolone Sodium Phosphate Orally Disintegrating Tablets due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0830-2018·2018-05-30

    Mylan Recalls Prednisolone Sodium Phosphate Orally Disintegrating Tablets

    Mylan Pharmaceuticals Inc. is voluntarily recalling PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets due to CGMP deviations.

    Product
    PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0831-2018·2018-05-30

    Mylan Recalls Prednisolone Sodium Phosphate Tablets Due to Manufacturing Deviations

    Mylan Pharmaceuticals is voluntarily recalling specific lots of Prednisolone Sodium Phosphate tablets due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only, 48-count bottle, NDC 00378-4730-22
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0819-2018·2018-05-23

    Mylan Recalls Amlodipine and Benazapril Capsules Due to Cleaning Deviations

    Mylan Pharmaceuticals is recalling specific lots of Amlodipine and Benazapril HCL Capsules because the cleaning process for manufacturing equipment was not followed according to procedure.

    Product
    Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0820-2018·2018-05-23

    Mylan Recalls Amlodipine and Benazapril Capsules Due to Cleaning Deviations

    Mylan Pharmaceuticals is recalling Amlodipine and Benazapril HCL Capsules because cleaning processes for manufacturing equipment were not followed according to procedure.

    Product
    Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0230-2018·2018-01-31

    Mylan Recalls Bupropion HCL Extended-Release Tablets Due to Impurities

    Mylan Pharmaceuticals is voluntarily recalling specific bottles of bupropion HCL extended-release tablets due to out-of-specification impurities found during routine stability testing.

    Product
    bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC: 0378-2009-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0920-2017·2017-06-21

    Mylan Recalls Montelukast Sodium Oral Granules Due to Impurity Failures

    Mylan Pharmaceuticals is recalling 11,624 pouches of Montelukast Sodium Oral Granules, 4 mg, due to failed impurity specifications.

    Product
    Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0706-2017·2017-05-31

    Mylan Recalls Alprazolam Extended-Release Tablets for Dissolution Failures

    Mylan Pharmaceuticals is recalling specific lots of Alprazolam Extended-Release Tablets because they failed to meet dissolution specifications.

    Product
    Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Manufactured and Distributed by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5022-91
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0861-2017·2017-05-31

    Mylan Recalls Norethindrone Acetate and Ethinyl Estradiol Tablets Due to Contamination

    Mylan Pharmaceuticals is recalling specific lots of oral contraceptive tablets due to chemical contamination from paint thinner vapors during facility repairs.

    Product
    NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL — NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0860-2017·2017-05-31

    Mylan Recalls Tarina Fe 1/20 Tablets Due to Chemical Contamination

    Mylan Pharmaceuticals is recalling Tarina Fe 1/20 tablets due to chemical contamination from paint thinner vapors during manufacturing.

    Product
    Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 blister pack containing 28 tablets (NDC 50102-128-01), packaged in 3 pouches, each pouch contains one blister pack of 28 tablets (NDC 50102-128-03), Rx only, Manufactured for
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0621-2017·2017-04-05

    Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination

    Mylan Pharmaceuticals is recalling Atorvastatin Calcium Tablets, 80 mg, due to potential microbial contamination and elevated bioburden.

    Product
    Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC 0378-3953-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide