Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Amiodarone Hydrochloride Injection Recalled by Mylan Institutional LLC Due to Labeling: Label Mix-Up; potential for cartons labeled as...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Mylan Institutional LLC directly.
Affected Products
Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial (NDC 67457-153-99); 10 x 9 mL Single-Dose Vials per carton (NDC 67457-153-09), Rx only, Manufactured by: Mylan Institutional, Galway, Ireland; Manufactured for: Mylan Institutional LLC, Rockford, IL 61103.
Quantity: 13,682 cartons
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Mylan Institutional LLC
Mylan Institutional LLC has 15 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report