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.

1–25 of 82

  • ModerateFDA (Drugs)·D-0774-2026·2026-08-26

    Mylan Recalls Acamprosate Calcium Tablets Due to Dissolution Failure

    Mylan Pharmaceuticals is recalling Acamprosate Calcium tablets that failed to meet dissolution specifications.

    Product
    ACAMPROSATE CALCIUM — ACAMPROSATE CALCIUM (ACAMPROSATE CALCIUM ENTERIC-COATED)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0734-2026·2026-08-05

    Mycophenolate Mofetil Injection Recalled Due to Precipitate in Vials

    Mylan Pharmaceuticals is recalling one lot of Mycophenolate Mofetil for Injection, 500 mg/vial, because precipitate was found in the vials. The recall covers 5,688 vials distributed nationwide.

    Product
    MYCOPHENOLATE MOFETIL — MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0280-2025·2025-03-26

    Prasugrel 5 mg Tablets Recalled Due to Failed Dissolution Specifications

    Mylan Pharmaceuticals is recalling specific lots of Prasugrel 5 mg tablets due to failed dissolution specifications. The affected tablets may not dissolve properly in the body.

    Product
    PRASUGREL — PRASUGREL (PRASUGREL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1292-2022·2022-08-03

    Insulin Glargine Prefilled Pens Recalled for Missing Label

    Mylan Pharmaceuticals is recalling Insulin Glargine prefilled pens (lot BF21002895) distributed nationwide because some pens lack labels, which could prevent patients from properly identifying and administering the medication.

    Product
    Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in cartons of 5 prefilled pens (NDC 49502-394-75), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 15317, Manufactured for: Mylan Specia
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0845-2022·2022-05-04

    Insulin Glargine Injection Vials Recalled Due to Missing Labels

    Mylan Pharmaceuticals is recalling 89,665 vials of Insulin Glargine Injection (100 units/mL) due to missing labels on the vials. Affected patients should not use the product and should contact their healthcare provider.

    Product
    Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multiple-Dose vial inside a carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Manufactured for: Mylan Specialty L.P., Morgantown, WV 26505, NDC 49502-39
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0774-2022·2022-04-27

    Injectable Rifampin Recalled Due to Failed Quality Specifications

    Mylan Pharmaceuticals is recalling injectable Rifampin vials nationwide due to failed impurities and degradation specifications discovered during stability testing.

    Product
    RIFAMPIN — RIFAMPIN (RIFAMPIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0748-2022·2022-04-13

    Prescription Eye Drop Medication Recalled for Subpotency and Contamination

    Mylan Pharmaceuticals recalls one lot of Travoprost ophthalmic solution due to subpotency and impurity issues found during stability testing. Patients should consult their pharmacist or physician if they have medication from this lot.

    Product
    TRAVOPROST OPHTHALMIC SOLUTION, 0.004% — TRAVOPROST OPHTHALMIC SOLUTION, 0.004% (TRAVOPROST OPHTHALMIC SOLUTION, 0.004%)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0452-2022·2022-02-02

    Proctofoam Topical Aerosol Recalled for cGMP Manufacturing Deficiencies

    Mylan Pharmaceuticals Inc is voluntarily recalling Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol due to current Good Manufacturing Practice (cGMP) deficiencies. The recall affects 233,199 10-gram aerosol containers distributed nationwide.

    Product
    PROCTOFOAM — PROCTOFOAM (PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0462-2022·2022-01-26

    Semglee Insulin Glargine Prefilled Pens Missing Label

    Mylan Pharmaceuticals is recalling approximately 73,175 Semglee (insulin glargine) prefilled pens nationwide because some units have a missing label. Patients should check their pens and contact their pharmacist or doctor if affected.

    Product
    Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 mL Prefilled Pens per carton (NDC 49502-0196-75), Rx only, Manufactured in Malaysia for: Mylan Specialty L.P., Morgantown, WV, 26505.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0049-2021·2020-10-28

    Mylan Recalls Candesartan Cilexetil and Hydrochlorothiazide Tablets Due to Impurity

    Mylan Pharmaceuticals is recalling specific lots of Candesartan Cilexetil and Hydrochlorothiazide tablets due to out-of-specification organic impurities found during routine stability testing.

    Product
    CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE — CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1031-2020·2020-03-25

    Mylan Recalls Sotalol HCL Tablets Due to Metal Particles

    Mylan Pharmaceuticals is recalling Sotalol HCL 80 mg tablets because of the presence of metal particles. The affected lot was distributed nationwide.

    Product
    Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0791-2020·2020-01-29

    Mylan Recalls Nizatidine Capsules Due to NDMA Impurity Detection

    Mylan Pharmaceuticals is recalling Nizatidine Capsules 150 mg because trace amounts of the impurity NDMA were detected in the active ingredient.

    Product
    Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0792-2020·2020-01-29

    Mylan Recalls Nizatidine Capsules Due to NDMA Impurity Detection

    Mylan Pharmaceuticals is recalling Nizatidine Capsules 300 mg because trace amounts of the impurity NDMA were detected in the active ingredient.

    Product
    Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0186-2020·2019-11-13

    Mylan Recalls Alprazolam Tablets Due to Foreign Substance Presence

    Mylan Pharmaceuticals is recalling Alprazolam 0.5 mg tablets because they contain a foreign substance. Consumers should stop using the affected lot and contact their pharmacist.

    Product
    Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Made in Australia, NDC 0378-4003-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1848-2019·2019-09-18

    Mylan Recalls Gatifloxacin Ophthalmic Solution Due to Unknown Impurity

    Mylan Pharmaceuticals is recalling Gatifloxacin Ophthalmic Solution 0.5% due to an out-of-specification result for an unknown impurity.

    Product
    Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. Made in India. NDC: 0378-5431-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0506-2019·2019-02-27

    Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

    Mylan Pharmaceuticals is recalling Diltiazem HCl Extended-Release Capsules 180mg because routine stability testing found high out-of-specification impurities.

    Product
    Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Food)·F-0859-2019·2019-02-20

    Mylan Recalls DrNatura Probiotics and Detox Kits for Undeclared Soy

    Mylan Pharmaceuticals is recalling DrNatura Flora Protect Probiotics and Toxinout Kits due to an undeclared soy allergen statement.

    Product
    DrNatura Toxinout Kit Broad Spectrum Detoxification Program
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0424-2019·2019-02-13

    Mylan Recalls Dymista Nasal Spray Due to Broken Glass Risk

    Mylan Pharmaceuticals is recalling 10,390 bottles of Dymista nasal spray because the glass bottles may have broken glass in the neck area.

    Product
    DYMISTA — DYMISTA (AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0428-2019·2019-02-06

    Mylan Recalls Fexofenadine Tablets Due to Elevated Impurities

    Mylan Pharmaceuticals is recalling specific lots of Fexofenadine HCl 180 mg tablets because routine stability testing showed slightly elevated related compounds.

    Product
    Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC 0378-0782-05); Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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
  • SevereFDA (Drugs)·D-0317-2019·2018-12-19

    Mylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Mylan Pharmaceuticals is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because FDA labs confirmed the presence of the impurity N-nitrosodiethylamine (NDEA).

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    0 states