Is Ropivacaine recalled?

54 FDA recalls mention Ropivacaine. The most recent are listed below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Ropivacaine.

Class II · Moderate risk Ongoing Jul 16, 2026

Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials…

Reason Presence of Particulate Matter: Hair was found in products

Fresenius Kabi USA, LLC D-0727-2026

Class II · Moderate risk Ongoing Oct 10, 2025

R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50…

Reason Presence of Particulate Matter

QuVa Pharma, Inc. NDC 70092-1433-50 D-0113-2026

Class II · Moderate risk Ongoing Sep 23, 2025

Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave…

Reason CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.

Park Avenue Compounding NDC 83863-4272-1 D-0178-2026

Class I · High risk Ongoing Apr 17, 2025

Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt. Ltd…

Reason Presence of Particulate Matter

Amneal Pharmaceuticals, LLC NDC 70121-1734-1 D-0402-2025

Class II · Moderate risk Ongoing Apr 15, 2025

FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural Use…

Reason Lack of Assurance of Sterility

Apollo Care, LLC NDC 71170-950-25 D-0409-2025

Class II · Moderate risk Ongoing Mar 6, 2025

fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF…

Reason Lack of Assurance of Sterility

QuVa Pharma, Inc. D-0297-2025

Class II · Moderate risk Completed Nov 29, 2023

ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 mL bags, Rx only, STAQ Pharma Inc. 14135…

Reason STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source…

STAQ Pharma, Inc. NDC 73177-0109-26 D-0147-2024

Class II · Moderate risk Ongoing May 2, 2023

FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo…

Reason Lack of Assurance of Sterility

Apollo Care, LLC NDC 71170-950-25 D-0646-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial, Rx Only, Manufactured by: Akorn Inc., Lake…

Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc. D-0863-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Single-dose Vial, Rx Only, Manufactured by: Akorn…

Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc. D-0842-2023

Class II · Moderate risk Ongoing Feb 8, 2023

Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only…

Reason Lack of assurance of sterility: Suspected microbial growth present on external label packaging.

Apollo Care NDC 71170-950-25 D-0487-2023

Class II · Moderate risk Terminated Jun 30, 2022

Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ketorolac Tromethamine 15 mg (0.3 mg/mL) Injection, 50…

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC D-1278-2022

Class II · Moderate risk Terminated Dec 17, 2020

fentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA…

Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

SCA Pharmaceuticals D-0191-2021

Class III · Low risk Terminated Apr 23, 2020

R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounded by QuVa…

Reason Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac

QuVa Pharma, Inc. D-1335-2020

Class II · Moderate risk Terminated Nov 12, 2019