Fentanyl Pf recalls

The FDA has published 9 recalls involving Fentanyl Pf since 2015. The latest was reported on 22 Oct 2025. Most were for sterility. QuVa 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 recalls9since 2015

Last 12 months1reported

Class I222% of total

Ongoing6latest 22 Oct 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 3Apr 0 0 0Jul 0 0 1Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 2 22%Class II 6 67%Class III 1 11%

Why fentanyl pf is recalled

Companies

By year

2025444%
2024222%
2017111%
2016111%
2015111%

Ongoing fentanyl pf recalls

6 active

Reported	Class	Recall	Company	Reason	Where
22 Oct 2025Drug	CLASS III	FentaNYL Citrate PF, 500mcg/ (10mcg/mL) in Nacl recalled by STAQ Pharma	Staq Pharma	Other	Nationwide
2 Apr 2025Drug	CLASS II	fentaNYL Citrate PF 200 mcg recalled by QuVa Pharma	QuVa Pharma	Sterility	Nationwide
2 Apr 2025Drug	CLASS II	fentaNYL Citrate PF 200 mcg recalled by QuVa Pharma	QuVa Pharma	Sterility	Nationwide
2 Apr 2025Drug	CLASS II	fentaNYL Citrate PF 200 mcg recalled by QuVa Pharma	QuVa Pharma	Sterility	Nationwide
7 Feb 2024Drug	CLASS I	FentaNYL citrate PF, 2500 mcg per 0.9% Sodium Chloride recalled	Denver Solutions	Potency & Assay	Nationwide
7 Feb 2024Drug	CLASS I	FentaNYL citrate PF, 1000 mcg per 0.9% Sodium Chloride recalled	Denver Solutions	Potency & Assay	Nationwide

All fentanyl pf recalls, newest first

9 total

Reported	Class	Recall	Company	Reason	Where
22 Oct 2025Drug	CLASS III	FentaNYL Citrate PF, 500mcg/ (10mcg/mL) in Nacl recalled by STAQ Pharma	Staq Pharma	Other	Nationwide
2 Apr 2025Drug	CLASS II	fentaNYL Citrate PF 200 mcg recalled by QuVa Pharma	QuVa Pharma	Sterility	Nationwide
2 Apr 2025Drug	CLASS II	fentaNYL Citrate PF 200 mcg recalled by QuVa Pharma	QuVa Pharma	Sterility	Nationwide
2 Apr 2025Drug	CLASS II	fentaNYL Citrate PF 200 mcg recalled by QuVa Pharma	QuVa Pharma	Sterility	Nationwide
7 Feb 2024Drug	CLASS I	FentaNYL citrate PF, 2500 mcg per 0.9% Sodium Chloride recalled	Denver Solutions	Potency & Assay	Nationwide
7 Feb 2024Drug	CLASS I	FentaNYL citrate PF, 1000 mcg per 0.9% Sodium Chloride recalled	Denver Solutions	Potency & Assay	Nationwide
1 Nov 2017Drug	CLASS II	fentanyl citrate (PF) 1100 mcg (20 mcg/mL) syringes recalled	Banner Pharmacy Services	Sterility	Nationwide
3 Feb 2016Drug	CLASS II	Fentanyl Citrate (PF) 50 mcg/mL, injectable recalled	Pharmakon Pharmaceuticals	Potency & Assay	Nationwide
25 Nov 2015Drug	CLASS II	Fentanyl PF (25 mcg/mL) Single Use Syringe, For IV recalled	US Compounding	Sterility	Nationwide

Should you stop taking Fentanyl Pf?

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.