Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Amiodarone Hydrochloride Injection Recalled by AuroMedics Pharma LLC Due to Crystallization: Presence of visible particulate matter.
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 AuroMedics Pharma LLC directly.
Affected Products
Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-182-18
Quantity: 138,720 vials
Why Was This Recalled?
Crystallization: Presence of visible particulate matter.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About AuroMedics Pharma LLC
AuroMedics Pharma LLC has 36 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report