Class II · Moderate risk
0.2% ROPivacaine - OnQ Pump
Lack of Assurance of Sterility: Potential leakage of bags.
Is Ropivacaine recalled?
Yes — there is an active recall. 10 ongoing FDA recalls mention Ropivacaine (54 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ropivacaine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Ropivacaine recalls on record
none so far in 2026; 54 on record, newest first
Class II · Moderate risk
Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump…
Lack of sterility assurance.
Class II · Moderate risk
Ropivacaine HCl 2 mg/mL 550 mL. Rx Only. Packaged in a ON-Q Pump…
Lack of sterility assurance.
Class II · Moderate risk
Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump…
Lack of sterility assurance.
Class II · Moderate risk
0.2% Ropivacaine HCI
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
Class II · Moderate risk
Ropivacaine HCl Injection in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Ropivacaine HCl in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Fentanyl Citrate and Ropivacaine HCl in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
fentaNYL as citrate 2 mcg / mL
Lack Of Assurance Of Sterility.
Class II · Moderate risk
Ropivacaine HCL
Lack of Assurance of Sterility.
Class II · Moderate risk
Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Class II · Moderate risk
fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
Fentanyl Citrate with Ropivacaine HCl all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Ropivacaine HCl in 0.9% Sodium Chloride all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class III · Low risk
Ropivacaine HCl 0.2% 550 mL Total Volume in an AutoFuser Pump in…
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Ropivacaine HCl 0.2% 750 mL Total Volume in an ON-Q Pump in 0.9%…
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9%…
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9%…
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Ropivacaine HCl 0.2% 400 mL Total Volume in an ON-Q Pump in 0.9%…
Labeling: Incorrect or Missing Lot and/or Exp Date
Class II · Moderate risk
Ropivacaine HCl 0.25% in 0.9% Sodium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Ropivacaine HCI 0.2% in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Fentanyl Citrate 2mcg/mL & Ropivacaine HCI 0.2% in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium…
Lack of Assurance of Sterility
Class II · Moderate risk
Fentanyl Citrate 2 mcg/mL/Ropivacaine HCI 0.2% injection in 0.9% Sodium Chloride
Lack of Assurance of Sterility
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