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

Is NDC 67457-0153-99 recalled?

Amiodarone Hydrochloride

Yes — this exact package was recalled

1 FDA recall names the code 67457-0153-99 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
amiodarone hydrochloride
Strength
AMIODARONE HYDROCHLORIDE 50 mg/mL
Form
Injection, Solution · Intravenous
Labeler
Mylan Institutional LLC
Type
Human Prescription Drug
Product code
67457-0153

Recalls naming this package

Class I · High risk

Amiodarone Hydrochloride 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 67457-153-99 D-1575-2020
Class II · Moderate risk

Amiodarone HCl Injection

Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical Inc., one of the distributing wholesalers.

Terminated Temperature excursion Mckesson NDC 67457-153-09 D-0005-2015

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