Linezolid recalls

The FDA has published 4 recalls involving Linezolid since 2016. The latest was reported on 9 May 2018. Most were for mold. 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 recalls4since 2016

Last 12 months0reported

Class I125% of total

Ongoing0latest 9 May 2018

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 0 0

Severity split

Class I 1 25%Class II 3 75%Class III 0 0%

Why linezolid is recalled

Companies

AuroMedics Pharma250%
Teva North America250%

By year

2018250%
2016250%

All linezolid recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
9 May 2018Drug	CLASS II	Linezolid Injection 600 mg recalled by AuroMedics PharmaLinezolid	AuroMedics Pharma	Mold	Nationwide
14 Feb 2018Drug	CLASS I	Linezolid Injection 600 mg/ (2 mg/mL) Single-use recalledLinezolid	AuroMedics Pharma	Mold	NJ
14 Sep 2016Drug	CLASS II	Linezolid Injection 600 mg recalled by Teva North America	Teva North America	Manufacturing (CGMP) Deviations	Nationwide
1 Jun 2016Drug	CLASS II	Linezolid Injection, 600 mg/ Single use container bags recalled	Teva North America	Sterility	Nationwide

Should you stop taking Linezolid?

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.