Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 67457-0197-00 recalled?

Tranexamic Acid

Yes — this exact package was recalled

1 FDA recall names the code 67457-0197-00 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

Active ingredient
tranexamic acid
Strength
TRANEXAMIC ACID 100 mg/mL
Form
Injection, Solution · Intravenous
Labeler
Mylan Institutional LLC
Type
Human Prescription Drug
Product code
67457-0197

Recalls naming this package

Class I · High risk

Tranexamic Acid Injection

Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.

Terminated Labeling / mix-up Mylan Institutional LLC NDC 67457-197-00 D-1576-2020

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler