FDA Drug Recalls

Recalls / Active ingredient / Tranexamic Acid

Tranexamic Acid

5 FDA drug recalls involving the active ingredient “Tranexamic Acid1 Class I.

DateClassProductFirm
2023-06-13Class IIITranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TAVKARE LLC
2023-06-12Class IIILysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring PharmaAmring Pharmaceuticals Inc
2022-09-26Class IIITranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC
2020-08-17Class ITranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose Vial (NDC 67457-197-00); 10 x 10 Mylan Institutional LLC
2013-10-31Class IITranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fresenius Kabi USA, LLC Packaged unFresenius Kabi USA, LLC