Mylan Institutional recalls

Mylan Institutional has 24 recalls on record with the FDA and USDA, the earliest in 2015 and the latest reported on 26 Mar 2025. 8 are still ongoing. The most frequent reason is potency & assay.

Total recalls24since 2015

Last 12 months0reported

Class I1042% of total

Ongoing8latest 26 Mar 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 6 0 0Feb 2 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 10 42%Class II 11 46%Class III 3 13%

Why mylan institutional is recalled

Product types

Injectable & IV Drugs1667%
Thyroid Medication833%

Brands

By year

202528%
2024625%
202114%
2020417%
201914%
20151042%

Ongoing mylan institutional recalls

8 active

Reported	Class	Recall	Company	Reason	Where
26 Mar 2025Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg) recalledLevothyroxine Sodium	Mylan Institutional	Potency & Assay	Nationwide
26 Mar 2025Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg) recalledLevothyroxine Sodium	Mylan Institutional	Potency & Assay	Nationwide
18 Dec 2024Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 137 mcg recalledLevothyroxine Sodium	Mylan Institutional	Potency & Assay	Nationwide
18 Dec 2024Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 112 mcg recalledLevothyroxine Sodium	Mylan Institutional	Potency & Assay	Nationwide
18 Dec 2024Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 150 mcg recalledLevothyroxine Sodium	Mylan Institutional	Potency & Assay	Nationwide
18 Dec 2024Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 100 mcg recalledLevothyroxine Sodium	Mylan Institutional	Potency & Assay	Nationwide

All mylan institutional recalls, newest first

24 total

Reported	Class	Recall	Company	Reason	Where
26 Mar 2025Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg) recalledLevothyroxine Sodium	Mylan Institutional	Potency & Assay	Nationwide
26 Mar 2025Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg) recalledLevothyroxine Sodium	Mylan Institutional	Potency & Assay	Nationwide
18 Dec 2024Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 137 mcg recalledLevothyroxine Sodium	Mylan Institutional	Potency & Assay	Nationwide
18 Dec 2024Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 112 mcg recalledLevothyroxine Sodium	Mylan Institutional	Potency & Assay	Nationwide
18 Dec 2024Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 150 mcg recalledLevothyroxine Sodium	Mylan Institutional	Potency & Assay	Nationwide
18 Dec 2024Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 100 mcg recalledLevothyroxine Sodium	Mylan Institutional	Potency & Assay	Nationwide
18 Dec 2024Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 175 mcg recalledLevothyroxine Sodium	Mylan Institutional	Potency & Assay	Nationwide
18 Dec 2024Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 125 mcg recalledLevothyroxine Sodium	Mylan Institutional	Potency & Assay	Nationwide
9 Jun 2021Drug	CLASS III	Thiamine HCl Injection, USP 200 mg/ (100mg/mL) vials recalledThiamine Hydrochloride	Mylan Institutional	Packaging Defects	Nationwide
9 Sep 2020Drug	CLASS I	Amiodarone Hydrochloride Injection, USP, 450 mg recalledAmiodarone Hydrochloride	Mylan Institutional	Packaging Defects	Nationwide
9 Sep 2020Drug	CLASS I	Tranexamic Acid Injection, USP, 1000 mg recalled by Mylan InstitutionalTranexamic Acid	Mylan Institutional	Packaging Defects	Nationwide
12 Aug 2020Drug	CLASS I	Daptomycin for Injection, 500 mg/vial, Single-Dose Vial recalledDaptomycin	Mylan Institutional	Particulate Matter	Nationwide
27 May 2020Drug	CLASS II	Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial recalledAloprim	Mylan Institutional	Potency & Assay	Nationwide
20 Mar 2019Drug	CLASS I	Levoleucovorin Injection, 250 mg/, (10 mg/mL) Single-Use Vial recalled	Mylan Institutional	Particulate Matter	Nationwide
26 Aug 2015Drug	CLASS I	Gemcitabine for Injection, USP*/vial, Lyophilized powder recalled	Mylan Institutional	Particulate Matter	Nationwide
26 Aug 2015Drug	CLASS I	Gemcitabine for Injection, USP, 200 mg*/vial recalled	Mylan Institutional	Particulate Matter	Nationwide
26 Aug 2015Drug	CLASS I	Gemcitabine for Injection, USP*/vial, Lyophilized powder recalled	Mylan Institutional	Particulate Matter	Nationwide
26 Aug 2015Drug	CLASS I	CARBOplatin Injection 450 mg/ (10 mg/mL) recalled by Mylan Institutional	Mylan Institutional	Particulate Matter	Nationwide
19 Aug 2015Drug	CLASS I	Methotrexate Injection, USP 50 mg/ (25 mg/mL) Single-dose Vial recalled	Mylan Institutional	Particulate Matter	Nationwide
19 Aug 2015Drug	CLASS I	Cytarabine Injection 100 mg/ (20 mg/mL) Single-Dose Vial recalled	Mylan Institutional	Particulate Matter	Nationwide
1 Apr 2015Drug	CLASS II	Haloperidol Decanoate Injection, 50 mg/mL recalledHaloperidol Decanoate	Mylan Institutional	Sterility	Nationwide
1 Apr 2015Drug	CLASS II	Haloperidol Decanoate Injection, 100 mg/mL recalledHaloperidol Decanoate	Mylan Institutional	Sterility	Nationwide
25 Mar 2015Drug	CLASS III	DOXOrubicin Hydrochloride Injection, USP, 200 mg/ (2 mg/mL) recalled	Mylan Institutional	Packaging Defects	Nationwide
25 Mar 2015Drug	CLASS III	Nicardipine Hydrochloride Injection, 25 mg recalled	Mylan Institutional	Potency & Assay	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.