Fentanyl recalls

The FDA has published 21 recalls involving Fentanyl since 2014. The latest was reported on 26 Feb 2025. Most were for potency & assay. 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 recalls21since 2014

Last 12 months0reported

Class I210% of total

Ongoing2latest 26 Feb 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 1 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 2 10%Class II 15 71%Class III 4 19%

Why fentanyl is recalled

Companies

Brands

Fentanyl Citrate524%
Fentanyl System210%

By year

202515%
202315%
2020419%
2019314%
2018210%
2016629%
2015210%
2014210%

Ongoing fentanyl recalls

2 active

Reported	Class	Recall	Company	Reason	Where
26 Feb 2025Drug	CLASS I	Fentanyl Transdermal System CII, 25mcg/h recalled by AlvogenFentanyl System	Alvogen	Packaging Defects	Nationwide
7 Jun 2023Drug	CLASS II	Fentanyl Citrate Injection, USP 100 mcg/ (50 mcg/mL) recalled by Akorn	Akorn	Potency & Assay	Nationwide

All fentanyl recalls, newest first

21 total

Reported	Class	Recall	Company	Reason	Where
26 Feb 2025Drug	CLASS I	Fentanyl Transdermal System CII, 25mcg/h recalled by AlvogenFentanyl System	Alvogen	Packaging Defects	Nationwide
7 Jun 2023Drug	CLASS II	Fentanyl Citrate Injection, USP 100 mcg/ (50 mcg/mL) recalled by Akorn	Akorn	Potency & Assay	Nationwide
12 Aug 2020Drug	CLASS II	Fentanyl Citrate Inj., USP 100 mcg Fentanyl recalled by PfizerFentanyl Citrate	Pfizer	Foreign Material	PR
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 Injection, 50 mcg per mL recalled	PharMEDium Services	Sterility	Nationwide
8 Apr 2020Drug	CLASS III	Fentanyl Citrate Injection, USP, 100 mcg/ (50 mcg/mL) recalled by Akorn	Akorn	Potency & Assay	Nationwide
23 Oct 2019Drug	CLASS II	Fentanyl Citrate USP, Active Pharmaceutical Ingredient recalled	Spectrum Laboratory Products	Foreign Material	4 states
15 May 2019Drug	CLASS I	Fentanyl Transdermal System, 12 mcg/h, five (12 mcg/h) systems recalledFentanyl System	Alvogen	Packaging Defects	Nationwide
1 May 2019Drug	CLASS III	Fentanyl Citrate Injection, USP, 100 mcg/ (50 mcg/mL) recalled by Akorn	Akorn	Potency & Assay	Nationwide
4 Jul 2018Drug	CLASS II	fentanyl Citrate USP 5 mcg in 9% Sodium Chloride recalled	Advanced Pharma	Potency & Assay	TX

Should you stop taking Fentanyl?

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.