Sufentanil recalls

The FDA has published 12 recalls involving Sufentanil since 2015. The latest was reported on 19 Jan 2022. 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 recalls12since 2015

Last 12 months0reported

Class I00% of total

Ongoing0latest 19 Jan 2022

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 12 100%Class III 0 0%

Why sufentanil is recalled

Companies

By year

202218%
2020325%
2016542%
2015325%

All sufentanil recalls, newest first

12 total

Reported	Class	Recall	Company	Reason	Where
19 Jan 2022Drug	CLASS II	Sufentanil Citrate Injection, USP 100 mcg/ (50 mcg/mL) recalled by Akorn	Akorn	Potency & Assay	Nationwide
22 Jan 2020Drug	CLASS II	Sufentanil 300MCG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020Drug	CLASS II	Sufentanil 55.5 MCG/ML IN INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020Drug	CLASS II	Sufentanil 150MCG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
27 Jul 2016Drug	CLASS II	0.4 mcg/mL Sufentanil Citrate and 0.0625% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016Drug	CLASS II	1 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016Drug	CLASS II	0.5 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016Drug	CLASS II	0.4 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
20 Jul 2016Drug	CLASS II	Sufentanil Citrate 0.4mcg/mL & Bupivacaine recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
23 Sep 2015Drug	CLASS II	Sufentanil 45 mcg/ml + Bupivacaine 5 mg/ml Solution recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015Drug	CLASS II	Sufentanil 50 mcg/ml + Bupivacaine 0.25 mg/ml Solution recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015Drug	CLASS II	Sufentanil 50 mcg/ml Solution, Sterile-Preservative Free recalled	The Compounding Pharmacy of America	Sterility	Nationwide

Should you stop taking Sufentanil?

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.