Mylan Institutional recalls

Mylan Institutional appears in 24 official U.S. recall notices indexed by RecallRadar, most recently on 2025-03-26.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton,…
  FDA Drug · Class II · 2025-03-26 · Mylan Institutional
  Reason: Super-Potent Drug: Out of specification potency results were obtained.
• Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton,…
  FDA Drug · Class II · 2025-03-26 · Mylan Institutional
  Reason: Super-Potent Drug: Out of specification potency results were obtained.
• Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manuf…
  FDA Drug · Class II · 2024-12-18 · Mylan Institutional
  Reason: Subpotent and Superpotent Drug
• Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Man…
  FDA Drug · Class II · 2024-12-18 · Mylan Institutional
  Reason: Subpotent and Superpotent Drug
• Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Man…
  FDA Drug · Class II · 2024-12-18 · Mylan Institutional
  Reason: Subpotent and Superpotent Drug
• Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Man…
  FDA Drug · Class II · 2024-12-18 · Mylan Institutional
  Reason: Subpotent and Superpotent Drug
• Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Man…
  FDA Drug · Class II · 2024-12-18 · Mylan Institutional
  Reason: Subpotent and Superpotent Drug
• Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Man…
  FDA Drug · Class II · 2024-12-18 · Mylan Institutional
  Reason: Subpotent and Superpotent Drug
• Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 25 (2 mL multi-dose vial) per carton, Rx only, Manufactured for…
  FDA Drug · Class III · 2021-06-09 · Mylan Institutional
  Reason: 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.
• Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial (NDC 67457-153-99)
  FDA Drug · Class I · 2020-09-09 · Mylan Institutional
  Reason: 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 Tranexam…
• Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose Vial (NDC 67457-197-00)
  FDA Drug · Class I · 2020-09-09 · Mylan Institutional
  Reason: 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 Tranexam…
• Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan Institutional, LLC, Rockford, IL 61103 U…
  FDA Drug · Class I · 2020-08-12 · Mylan Institutional
  Reason: Presence of Particulate Matter
• Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103…
  FDA Drug · Class II · 2020-05-27 · Mylan Institutional
  Reason: 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.
• Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL…
  FDA Drug · Class I · 2019-03-20 · Mylan Institutional
  Reason: Presence of Particulate Matter: particulate matter identified as copper salts
• Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Roc…
  FDA Drug · Class I · 2015-08-26 · Mylan Institutional
  Reason: Presence of Particulate Matter
• Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Roc…
  FDA Drug · Class I · 2015-08-26 · Mylan Institutional
  Reason: Presence of Particulate Matter
• Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only, labeled as a) Manufactured for: Mylan Insti…
  FDA Drug · Class I · 2015-08-26 · Mylan Institutional
  Reason: Presence of Particulate Matter
• CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Multi-Dose Vial, Rx only, Manufactured for: Mylan Institutional L…
  FDA Drug · Class I · 2015-08-26 · Mylan Institutional
  Reason: Presence of Particulate Matter
• 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, labeled as a) Dis…
  FDA Drug · Class I · 2015-08-19 · Mylan Institutional
  Reason: Presence of Particulate Matter
• 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 carton (NDC 0069-015…
  FDA Drug · Class I · 2015-08-19 · Mylan Institutional
  Reason: Presence of Particulate Matter
• Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of te…
  FDA Drug · Class II · 2015-04-01 · Mylan Institutional
  Reason: Lack of Assurance of Sterility; due to leaking vials
• Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) packaged in cartons of f…
  FDA Drug · Class II · 2015-04-01 · Mylan Institutional
  Reason: Lack of Assurance of Sterility; due to leaking vials
• DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use Only, Sterile, ISOTONIC SOLUTION, Caution: Cytotoxic Agent, 1…
  FDA Drug · Class III · 2015-03-25 · Mylan Institutional
  Reason: 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
• Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutiona…
  FDA Drug · Class III · 2015-03-25 · Mylan Institutional
  Reason: Subpotent Drug and Failed Impurities/Degradation Specifications