Amiodarone Hydrochloride recalls

Amiodarone Hydrochloride products have been recalled 5 times, most recently on 9 Sep 2020. The recalling company is usually AuroMedics Pharma. The most common reason is particulate matter.

Total recalls5since 2014

Last 12 months0reported

Class I120% of total

Ongoing0latest 9 Sep 2020

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 1 20%Class II 1 20%Class III 3 60%

Why amiodarone hydrochloride is recalled

Companies

Product types

Injectable & IV Drugs5100%

By year

2020120%
2019360%
2014120%

All amiodarone hydrochloride recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
9 Sep 2020Drug	CLASS I	Amiodarone Hydrochloride Injection, USP, 450 mg recalledAmiodarone Hydrochloride	Mylan Institutional	Packaging Defects	Nationwide
4 Dec 2019Drug	CLASS III	Amiodarone Hydrochloride Injection, USP, 900 mg recalledAmiodarone Hydrochloride	AuroMedics Pharma	Particulate Matter	Nationwide
4 Dec 2019Drug	CLASS III	Amiodarone Hydrochloride Injection, USP, 450 mg recalledAmiodarone Hydrochloride	AuroMedics Pharma	Particulate Matter	Nationwide
4 Dec 2019Drug	CLASS III	Amiodarone Hydrochloride Injection, USP, 150 mg recalledAmiodarone Hydrochloride	AuroMedics Pharma	Particulate Matter	Nationwide
15 Oct 2014Drug	CLASS II	Amiodarone HCl Injection, 450 mg/ (50 mg per mL) Single-Use Vial recalledAmiodarone Hydrochloride	Mckesson	Temperature Abuse	MT, OR, WA

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.