Tranexamic Acid recalls

The FDA has published 5 recalls involving Tranexamic Acid since 2014. The latest was reported on 21 Jun 2023. Most were for potency & assay. Fresenius Kabi USA has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls5since 2014

Last 12 months0reported

Class I120% 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 20%Class II 1 20%Class III 3 60%

Why tranexamic acid is recalled

Companies

By year

2023240%
2022120%
2020120%
2014120%

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

5 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
29 Jan 2014Drug	CLASS II	Tranexamic Acid Injection USP, 1000mg/ vial recalled	Fresenius Kabi USA	Particulate Matter	Nationwide

Should you stop taking Tranexamic Acid?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.