TRANEXAMIC ACID
Generic: TRANEXAMIC ACID
i3 PharmaceuticalsManufacturer
ORALRoute
TRANEXAMIC ACIDActive Substance
2026-01-26Original Approval
TRANEXAMIC ACID is FDA application ANDA219702, sponsored by PHARMAZONE. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
Class III2022-09-26
Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedicsPresence of Particulate Matter: Piece of metal found in a vial
Class III2023-06-12
Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity
Class I2020-08-17
Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose Vial (NDC 67457-197-00); 10 x 10 mL Single-Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain v
Class III2023-06-13
Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NFailed Impurities/Degradation Specifications: Out of specification results obtained for conductivity
Top Reported Reactions
1
DRUG INEFFECTIVE
621 reports
2
OFF LABEL USE
617 reports
3
PYREXIA
340 reports
4
NAUSEA
311 reports
5
HYPOTENSION
307 reports
6
DIARRHOEA
302 reports
7
VOMITING
284 reports
8
HAEMORRHAGE
281 reports
9
DYSPNOEA
271 reports
10
PNEUMONIA
258 reports