Home / Brands / Mylan Institutional
Mylan Institutional Recalls
24 recalls on record · March 25, 2015 to March 26, 2025 · Drugs
Recalls by year
15
19
20
21
24
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 26, 2025DrugsFDA
Mylan Institutional, Inc. recalls Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablet
Hazard: Super-Potent Drug: Out of specification potency results were obtained.
March 26, 2025DrugsFDA
Mylan Institutional, Inc. recalls Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets
Hazard: Super-Potent Drug: Out of specification potency results were obtained.
December 18, 2024DrugsFDA
Mylan Institutional, Inc. recalls Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets
Hazard: Subpotent and Superpotent Drug
December 18, 2024DrugsFDA
Mylan Institutional, Inc. recalls Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets
Hazard: Subpotent and Superpotent Drug
December 18, 2024DrugsFDA
Mylan Institutional, Inc. recalls Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets
Hazard: Subpotent and Superpotent Drug
December 18, 2024DrugsFDA
Mylan Institutional, Inc. recalls Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets
Hazard: Subpotent and Superpotent Drug
December 18, 2024DrugsFDA
Mylan Institutional, Inc. recalls Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets
Hazard: Subpotent and Superpotent Drug
December 18, 2024DrugsFDA
Mylan Institutional, Inc. recalls Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets ea
Hazard: Subpotent and Superpotent Drug
June 9, 2021DrugsFDA
Mylan Institutional LLC recalls Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 25 (2 mL multi-dose vial) per carton, Rx onl
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901.
September 9, 2020DrugsFDA
Mylan Institutional LLC recalls Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose Vial (NDC 67457-197-00); 10 x 10 mL Single-
Hazard: Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
September 9, 2020DrugsFDA
Mylan Institutional LLC recalls Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial (NDC 67457-153-99); 10 x 9 mL Sin
Hazard: Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
August 12, 2020DrugsFDA
Mylan Institutional LLC recalls Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan Institutional, LLC, R
Hazard: Presence of Particulate Matter
May 27, 2020DrugsFDA
Mylan Institutional LLC recalls Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC,
Hazard: Discoloration: Out-of-specification results for appearance obtained during routine stability testing at the end of shelf-life for the parameters Appearance and Color of Solution.
March 20, 2019DrugsFDA
Mylan Institutional Inc recalls Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx only, Manufactured for: Mylan Institution
Hazard: Presence of Particulate Matter: particulate matter identified as copper salts
August 26, 2015DrugsFDA
Mylan Institutional LLC recalls Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Ins
Hazard: Presence of Particulate Matter
August 26, 2015DrugsFDA
Mylan Institutional LLC recalls Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Ins
Hazard: Presence of Particulate Matter
August 26, 2015DrugsFDA
Mylan Institutional LLC recalls Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only, labeled as a) Manufactur
Hazard: Presence of Particulate Matter
August 26, 2015DrugsFDA
Mylan Institutional LLC recalls CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Multi-Dose Vial, Rx only, Manufactured for: My
Hazard: Presence of Particulate Matter
August 19, 2015DrugsFDA
Mylan Institutional LLC recalls Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-0152-01), packaged in 10 x 5 mL Vials per c
Hazard: Presence of Particulate Matter
August 19, 2015DrugsFDA
Mylan Institutional LLC recalls Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, packaged in 5 x 2 mL vials per carton, Rx only
Hazard: Presence of Particulate Matter
April 1, 2015DrugsFDA
Mylan Institutional LLC recalls Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packag
Hazard: Lack of Assurance of Sterility; due to leaking vials
April 1, 2015DrugsFDA
Mylan Institutional LLC recalls Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) packa
Hazard: Lack of Assurance of Sterility; due to leaking vials
March 25, 2015DrugsFDA
Mylan Institutional LLC recalls Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for:
Hazard: Subpotent Drug and Failed Impurities/Degradation Specifications
March 25, 2015DrugsFDA
Mylan Institutional LLC recalls DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use Only, Sterile, ISOTONIC SOLUTION, Caution:
Hazard: Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may have been mis-packaged in a carton labeled Doxorubicin Hydrochloride Injection 2 mg/mL, 100 mL