Tranexamic Acid recalls

Tranexamic Acid products have been recalled 4 times, most recently on 21 Jun 2023. The recalling company is usually Mylan Institutional. The most common reason is potency & assay.

Total recalls4since 2020

Last 12 months0reported

Class I125% of total

Ongoing2latest 21 Jun 2023

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 1 25%Class II 0 0%Class III 3 75%

Why tranexamic acid is recalled

Companies

Product types

Injectable & IV Drugs250%

By year

2023250%
2022125%
2020125%

Ongoing tranexamic acid recalls

2 active

Reported	Class	Recall	Company	Reason	Where
21 Jun 2023Drug	CLASS III	Tranexamic Acid USP Tablets, 650 mg Unit Dose recalled by AVKARETranexamic Acid	AVKARE	Potency & Assay	Nationwide
12 Oct 2022Drug	CLASS III	Tranexamic Acid Injection, USP, 1000mg recalled by AuroMedics PharmaTranexamic Acid	AuroMedics Pharma	Particulate Matter	Nationwide

All tranexamic acid recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
21 Jun 2023Drug	CLASS III	Tranexamic Acid USP Tablets, 650 mg Unit Dose recalled by AVKARETranexamic Acid	AVKARE	Potency & Assay	Nationwide
21 Jun 2023Drug	CLASS III	Lysteda (tranexamic acid) USP Tablets, 650 mg recalledTranexamic Acid	Amring Pharmaceuticals	Potency & Assay	Nationwide
12 Oct 2022Drug	CLASS III	Tranexamic Acid Injection, USP, 1000mg recalled by AuroMedics PharmaTranexamic Acid	AuroMedics Pharma	Particulate Matter	Nationwide
9 Sep 2020Drug	CLASS I	Tranexamic Acid Injection, USP, 1000 mg recalled by Mylan InstitutionalTranexamic Acid	Mylan Institutional	Packaging Defects	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.