Fentanyl recalls

The FDA has published 248 recalls involving Fentanyl since 2012. The latest was reported on 16 Sep 2026. 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 recalls248since 2012

Last 12 months8reported

Class I125% of total

Ongoing15latest 16 Sep 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 2Feb 0 0 1May 0 0 0Aug 0 0 1Nov 0 0 0Feb 0 0 6May 0 0 0Aug 1 0

Severity split

Class I 12 5%Class II 229 92%Class III 7 3%

Why fentanyl is recalled

Companies

Pharmedium Services6627%
Central Admixture Pharmacy Services3514%
QuVa Pharma2711%
SCA Pharmaceuticals198%
Pharmakon Pharmaceuticals156%
Cantrell Drug73%
Advanced Pharma62%
Assurance Infusion62%

Brands

Fentanyl Citrate52%
Fentanyl System21%

By year

202673%
202542%
202473%
20234117%
202294%
202142%
2020104%
20194217%
2018114%
2017104%

Ongoing fentanyl recalls

15 active

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Drug	CLASS II	fentaNYL Citrate, 1,000 mcg recalled by OurPharma	OurPharma	Other	Nationwide
27 May 2026Drug	CLASS II	fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg recalled	IntegraDose Compounding Services	Potency & Assay	Nationwide
6 May 2026Drug	CLASS II	fentaNYL Citrate Injectable Solution recalled by Wells Pharma of Houston	Wells Pharma of Houston	Manufacturing (CGMP) Deviations	Nationwide
6 May 2026Drug	CLASS II	fentaNYL Citrate Injectable Solution, Narcotic, CII recalled	Wells Pharma of Houston	Manufacturing (CGMP) Deviations	Nationwide
6 May 2026Drug	CLASS II	fentaNYL Citrate Injectable Solution, Narcotic, Cii recalled	Wells Pharma of Houston	Manufacturing (CGMP) Deviations	Nationwide
6 May 2026Drug	CLASS II	fentaNYL Citrate injectable Solution recalled by Wells Pharma of Houston	Wells Pharma of Houston	Manufacturing (CGMP) Deviations	Nationwide

All fentanyl recalls, newest first

248 total

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Drug	CLASS II	fentaNYL Citrate, 1,000 mcg recalled by OurPharma	OurPharma	Other	Nationwide
27 May 2026Drug	CLASS II	fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg recalled	IntegraDose Compounding Services	Potency & Assay	Nationwide
6 May 2026Drug	CLASS II	fentaNYL Citrate Injectable Solution recalled by Wells Pharma of Houston	Wells Pharma of Houston	Manufacturing (CGMP) Deviations	Nationwide
6 May 2026Drug	CLASS II	fentaNYL Citrate Injectable Solution, Narcotic, CII recalled	Wells Pharma of Houston	Manufacturing (CGMP) Deviations	Nationwide
6 May 2026Drug	CLASS II	fentaNYL Citrate Injectable Solution, Narcotic, Cii recalled	Wells Pharma of Houston	Manufacturing (CGMP) Deviations	Nationwide
6 May 2026Drug	CLASS II	fentaNYL Citrate injectable Solution recalled by Wells Pharma of Houston	Wells Pharma of Houston	Manufacturing (CGMP) Deviations	Nationwide
6 May 2026Drug	CLASS II	fentaNYL Citrate Injectable Solution recalled by Wells Pharma of Houston	Wells Pharma of Houston	Manufacturing (CGMP) Deviations	Nationwide
26 Nov 2025Drug	CLASS II	Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS, CII recalled	Park Avenue Compounding	Manufacturing (CGMP) Deviations	MO
14 May 2025Drug	CLASS II	FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg recalled	Apollo Care	Sterility	MO
26 Feb 2025Drug	CLASS I	Fentanyl Transdermal System CII, 25mcg/h recalled by AlvogenFentanyl System	Alvogen	Packaging Defects	Nationwide
26 Feb 2025Drug	CLASS II	fentaNYL Citrate In Sodium Chloride 1600mcg recalled	Fagron Compounding Services	Sterility	PA
8 May 2024Drug	CLASS III	Fentanyl 1000mcg/ (10mcg/mL) in 0.9% Sodium Chloride Injection recalled	Hikma Injectables USA	Packaging Defects	Nationwide
10 Apr 2024Drug	CLASS II	FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride Vial recalled	SSM Health Care St. Louis	Sterility	MO
3 Apr 2024Drug	CLASS II	fentaNYL 200 mcg/, Bupivacaine HCl recalled by SCA Pharmaceuticals	SCA Pharmaceuticals	Sterility	Nationwide
3 Apr 2024Drug	CLASS II	fentaNYL 500 mcg/, Bupivacaine HCl recalled by SCA Pharmaceuticals	SCA Pharmaceuticals	Sterility	Nationwide
3 Apr 2024Drug	CLASS II	fentaNYL 200 mcg/, Bupivacaine HCl recalled by SCA Pharmaceuticals	SCA Pharmaceuticals	Sterility	Nationwide
3 Apr 2024Drug	CLASS II	fentaNYL 500 mcg/, Bupivacaine HCl recalled by SCA Pharmaceuticals	SCA Pharmaceuticals	Sterility	Nationwide
3 Apr 2024Drug	CLASS II	fentaNYL 100 mcg/, Bupivacaine HCl recalled by SCA Pharmaceuticals	SCA Pharmaceuticals	Sterility	Nationwide
11 Oct 2023Drug	CLASS II	fentaNYL in 0.9% sodium chloride, 1,000 mcg/, (10 mcg/mL) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
11 Oct 2023Drug	CLASS II	fentaNYL, 2500 mcg/, (50 mcg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
11 Oct 2023Drug	CLASS II	fentaNYL in 0.9% sodium chloride, 2,500 mcg/, (10 mcg/mL) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
11 Oct 2023Drug	CLASS II	fentaNYL in 0.9% sodium chloride, 5,000 mcg/, (20 mcg/mL) recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
11 Oct 2023Drug	CLASS II	fentaNYL in 0.9% sodium chloride, 500 mcg/, (10 mcg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
11 Oct 2023Drug	CLASS II	fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
11 Oct 2023Drug	CLASS II	fentaNYL, 2500 mcg/, (50 mcg/mL) recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
11 Oct 2023Drug	CLASS II	fentaNYL in dextrose 5%, 300 mcg/, (10 mcg/mL) syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
11 Oct 2023Drug	CLASS II	fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
11 Oct 2023Drug	CLASS II	fentaNYL, 250 mcg/, (50 mcg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
11 Oct 2023Drug	CLASS II	fentaNYL in 0.9% sodium chloride, 10 mcg/, (10 mcg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
11 Oct 2023Drug	CLASS II	fentaNYL in 0.9% sodium chloride, 100 mcg/, (10 mcg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide

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.