Fentanyl Citrate recalls

Fentanyl Citrate products have been recalled 5 times, most recently on 12 Aug 2020. The recalling company is usually Hospira. The most common reason is potency & assay.

Total recalls5since 2014

Last 12 months0reported

Class I00% of total

Ongoing0latest 12 Aug 2020

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 0 0%Class II 3 60%Class III 2 40%

Why fentanyl citrate is recalled

Companies

Product types

Pain Medication5100%

By year

2020120%
2015240%
2014240%

All fentanyl citrate recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
12 Aug 2020Drug	CLASS II	Fentanyl Citrate Inj., USP 100 mcg Fentanyl recalled by PfizerFentanyl Citrate	Pfizer	Foreign Material	PR
24 Jun 2015Drug	CLASS III	Fentanyl Citrate Inj., USP, CII, 250 mcg/ (50 mcg/mL) 05 mg/mL) recalledFentanyl Citrate	West-Ward Pharmaceutical	Potency & Assay	Nationwide
1 Apr 2015Drug	CLASS III	Fentanyl Citrate Inj., USP, CII, 250 mcg recalledFentanyl Citrate	West-Ward Pharmaceutical	Potency & Assay	Nationwide
17 Dec 2014Drug	CLASS II	Fentanyl Citrate Injection recalled by HospiraFentanyl Citrate	Hospira	Sterility	Nationwide
23 Jul 2014Drug	CLASS II	Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/, C-II recalledFentanyl Citrate	Hospira	Sterility	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.