Fentanyl Inj recalls

The FDA has published 3 recalls involving Fentanyl Inj since 2015. The latest was reported on 19 Feb 2020. Most were for potency & assay. West-Ward Pharmaceutical 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 recalls3since 2015

Last 12 months0reported

Class I00% of total

Ongoing0latest 19 Feb 2020

Recalls per month, last 24 months

click a bar for that month

0Dec '24 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0 0Dec 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0

Severity split

Class I 0 0%Class II 1 33%Class III 2 67%

Why fentanyl inj is recalled

Potency & Assay267%
Foreign Material133%

Companies

West-Ward Pharmaceutical267%
Pfizer133%

By year

2020133%
2015267%

All fentanyl inj recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
19 Feb 2020Drug	CLASS II	Fentanyl Citrate Inj., USP 100 mcg Fentanyl recalled by Pfizer	Pfizer	Foreign Material	Nationwide
24 Jun 2015Drug	CLASS III	Fentanyl Citrate Inj., USP, CII, 250 mcg/ (50 mcg/mL) (0.05 mg/mL) recalled	West-Ward Pharmaceutical	Potency & Assay	Nationwide
1 Apr 2015Drug	CLASS III	Fentanyl Citrate Inj., USP, CII, 250 mcg/ (50 mcg/mL) recalled	West-Ward Pharmaceutical	Potency & Assay	Nationwide

Should you stop taking Fentanyl Inj?

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.