Bupivacaine recalls

The FDA has published 54 recalls involving Bupivacaine since 2012. The latest was reported on 22 Apr 2026. Most were for sterility. Hospira 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 recalls54since 2012

Last 12 months1reported

Class I815% of total

Ongoing3latest 22 Apr 2026

Recalls per month, last 24 months

click a bar for that month

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

Severity split

Class I 8 15%Class II 45 83%Class III 1 2%

Why bupivacaine is recalled

Companies

Brands

By year

202612%
202512%
202336%
2022917%
202112%
202024%
201947%
201812%
201736%
201659%

Ongoing bupivacaine recalls

3 active

Reported	Class	Recall	Company	Reason	Where
22 Apr 2026Drug	CLASS II	Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection recalledBupivacaine Hydrochloride	Huons	Sterility	Nationwide
9 Jul 2025Drug	CLASS II	BUPIVAcaine HCL Sterile injection recalled by Tailstorm Health	Tailstorm Health	Sterility	Nationwide
28 Dec 2016Drug	CLASS I	Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) recalledBupivacaine Hydrochloride	Hospira Inc. A Pfizer	Particulate Matter	Nationwide

All bupivacaine recalls, newest first

54 total

Reported	Class	Recall	Company	Reason	Where
22 Apr 2026Drug	CLASS II	Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection recalledBupivacaine Hydrochloride	Huons	Sterility	Nationwide
9 Jul 2025Drug	CLASS II	BUPIVAcaine HCL Sterile injection recalled by Tailstorm Health	Tailstorm Health	Sterility	Nationwide
25 Jan 2023Drug	CLASS II	Sensorcaine (Bupivacaine HCl and Epinephrine Injection recalledSensorcaine	Fresenius Kabi USA	Potency & Assay	Nationwide
25 Jan 2023Drug	CLASS II	Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection recalledSensorcaine	Fresenius Kabi USA	Potency & Assay	Nationwide
25 Jan 2023Drug	CLASS II	Sensorcaine (Bupivacaine HCl and Epinephrine Injection recalledSensorcaine	Fresenius Kabi USA	Potency & Assay	Nationwide
24 Aug 2022Drug	CLASS III	Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine recalledZynrelef	Heron Therapeutics	Packaging Defects	Nationwide
27 Jul 2022Drug	CLASS II	0.125% Bupivacaine HCl Injection, USP, 62.5 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022Drug	CLASS II	Bupivacaine HCl 150 mg (3.0 mg/mL) recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
15 Jun 2022Drug	CLASS II	Bupivacaine HCl Injection, Single Dose Vial, 0.75%/7.5 mg/mL recalled	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
15 Jun 2022Drug	CLASS II	Bupivacaine HCl Injection, single dose vial, Preservative Free recalledBupivacaine Hydrochloride	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
15 Jun 2022Drug	CLASS II	Bupivacaine HCl Injection, single dose vial, 0.5%/5 mg/mL recalled	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
15 Jun 2022Drug	CLASS II	Bupivacaine HCl Injection, Multi dose vial, 0.25%/2.5 mg/mL recalled	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
15 Jun 2022Drug	CLASS II	Bupivacaine HCl Injection, Multi dose vial, 0.50%/5 mg/mL recalled	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
15 Jun 2022Drug	CLASS II	Bupivacaine Hydrochloride, USP 0.5% (5mg/mL), 25 vials recalledBupivacaine Hydrochloride	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
9 Jun 2021Drug	CLASS I	0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg recalled by PFIZERBupivacaine Hydrochloride	Pfizer	Packaging Defects	Nationwide
30 Dec 2020Drug	CLASS II	Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection recalledSensorcaine	Fresenius Kabi USA	Potency & Assay	Nationwide
18 Nov 2020Drug	CLASS II	Bupivacaine Hydrochloride in 8.25% Dextrose Injection recalled	Baxter Healthcare	Particulate Matter	Nationwide
18 Dec 2019Drug	CLASS II	Bupivacaine HCl and Hydromorphone HCl in all strengths recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019Drug	CLASS II	Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019Drug	CLASS II	Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
11 Dec 2019Drug	CLASS II	Exparel, Bupivicaine Liposome Injectable Suspension recalledExparel	Pacira Pharmaceuticals	Potency & Assay	Nationwide
28 Feb 2018Drug	CLASS II	Bupivacaine HCl in 0.9% Sodium Chloride in all doses recalled	Pharmedium Services	Sterility	Nationwide
2 Aug 2017Drug	CLASS II	BUPIVacaine HCl 0.2% IN 0.9% Sodium Chloride Bag recalled	SCA Pharmaceuticals	Sterility	Nationwide
2 Aug 2017Drug	CLASS II	BUPIVacaine HCl 0.125% In 0.9% Sodium Chloride recalled	SCA Pharmaceuticals	Sterility	Nationwide
31 May 2017Drug	CLASS II	Bupivacaine HCl in 0.9% Sodium Chloride all strengths recalled	Advanced Pharma	Packaging Defects	Nationwide
28 Dec 2016Drug	CLASS I	Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) recalledBupivacaine Hydrochloride	Hospira Inc. A Pfizer	Particulate Matter	Nationwide
19 Oct 2016Drug	CLASS II	Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg recalledMarcaine	Hospira Inc. A Pfizer	Foreign Material	Nationwide
19 Oct 2016Drug	CLASS II	Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg recalledMarcaine	Hospira Inc. A Pfizer	Foreign Material	Nationwide
20 Jul 2016Drug	CLASS II	Bupivacaine 1mg/mL injection in 0.9% Sodium Chloride recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
22 Jun 2016Drug	CLASS II	Sensorcaine- MPF (Bupivacaine HCI Injection, USP) recalledSensorcaine	Fresenius Kabi USA	Particulate Matter	Nationwide

Should you stop taking Bupivacaine?

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.