Naloxone* recalls

The FDA has published 4 recalls involving Naloxone* since 2014. The latest was reported on 7 Jun 2023. Most were for sterility. Akorn 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 recalls4since 2014

Last 12 months0reported

Class I125% of total

Ongoing1latest 7 Jun 2023

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 25%Class II 3 75%Class III 0 0%

Why naloxone* is recalled

Companies

Akorn125%
Cardinal Health125%
Hospira Inc Lake Forest125%
Specialty Medicine Compounding Pharmacy125%

Brands

Narcan125%
Naloxone Hydrochloride125%

By year

2023125%
2021125%
2018125%
2014125%

Ongoing naloxone* recalls

1 active

Reported	Class	Recall	Company	Reason	Where
7 Jun 2023Drug	CLASS II	Naloxone Injection, USP 0.4 mg/mL, For Intravenous recalled by Akorn	Akorn	Potency & Assay	Nationwide

All naloxone* recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
7 Jun 2023Drug	CLASS II	Naloxone Injection, USP 0.4 mg/mL, For Intravenous recalled by Akorn	Akorn	Potency & Assay	Nationwide
2 Jun 2021Drug	CLASS II	Narcan (naloxone HCl) Nasal Spray 4 mg Two Pack This box recalledNarcan	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
13 Jun 2018Drug	CLASS I	Naloxone Hydrochloride Injection, USP, 0.4 mg/mL recalledNaloxone Hydrochloride	Hospira Inc Lake Forest	Particulate Matter	Nationwide
22 Jan 2014Drug	CLASS II	Naloxone HCL* 0.4MG/ML Injectable, all sizes recalled	Specialty Medicine Compounding Pharmacy	Sterility	MI

Should you stop taking Naloxone*?

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.