Amiodarone recalls

The FDA has published 8 recalls involving Amiodarone since 2014. The latest was reported on 9 Sep 2026. Most were for particulate matter. AuroMedics Pharma has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls8since 2014

Last 12 months1reported

Class I225% of total

Ongoing1latest 9 Sep 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 1 0

Severity split

Class I 2 25%Class II 3 38%Class III 3 38%

Why amiodarone is recalled

Companies

Brands

Amiodarone Hydrochloride563%
Nexterone225%

By year

2026113%
2020113%
2019338%
2018225%
2014113%

Ongoing amiodarone recalls

1 active

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Nexterone (amiodarone HCI), 360 mg/ (1.8 mg/mL) recalledNexterone	Baxter Healthcare	Manufacturing (CGMP) Deviations	Nationwide

All amiodarone recalls, newest first

8 total

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Nexterone (amiodarone HCI), 360 mg/ (1.8 mg/mL) recalledNexterone	Baxter Healthcare	Manufacturing (CGMP) Deviations	Nationwide
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
7 Feb 2018Drug	CLASS I	Nexterone (amiodarone HCl) Premixed Injection, 150mg recalledNexterone	Baxter Healthcare	Particulate Matter	Nationwide
3 Jan 2018Drug	CLASS II	Amiodarone 900 mg in dextrose 5%, Concentration: 1.8 mg/mL recalled	SSM Health Care St. Louis	Sterility	MO
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

Should you stop taking Amiodarone?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.