Fentanyl Per Ml recalls

The FDA has published 5 recalls involving Fentanyl Per Ml since 2016. The latest was reported on 15 Apr 2020. Most were for sterility. Pharmedium Services 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 recalls5since 2016

Last 12 months0reported

Class I00% of total

Ongoing0latest 15 Apr 2020

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 0 0%Class II 5 100%Class III 0 0%

Why fentanyl per ml is recalled

Sterility480%
Potency & Assay120%

Companies

By year

2020360%
2018120%
2016120%

All fentanyl per ml recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
15 Apr 2020Drug	CLASS II	fentaNYL Citrate 10 mcg per mL, 2,500 mcg per in a LifeCare recalled	PharMEDium Services	Sterility	Nationwide
15 Apr 2020Drug	CLASS II	fentaNYL Citrate Injection 50 mcg per mL recalled by PharMEDium Services	PharMEDium Services	Sterility	Nationwide
15 Apr 2020Drug	CLASS II	fentaNYL Citrate 50 mcg per mL recalled by PharMEDium Services	PharMEDium Services	Sterility	Nationwide
25 Jul 2018Drug	CLASS II	fentaNYL (10 mcg per mL) in 0.95 Sodium Chloride recalled	Avella of Deer Valley Inc. Store 38	Sterility	Nationwide
19 Oct 2016Drug	CLASS II	Fentanyl Citrate 16.67 mcg per mL recalled by Pharmedium Services	Pharmedium Services	Potency & Assay	Nationwide

Should you stop taking Fentanyl Per Ml?

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.