Class II · Moderate risk
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection
Lack of Assurance of Sterility
Is Bupivacaine recalled?
Yes — there is an active recall. 5 ongoing FDA recalls mention Bupivacaine (306 total). Check the affected lots below.
Most common reason: Sterility / contamination (171 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Bupivacaine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Bupivacaine recalls in 2026
1 initiated in 2026, 306 in total — newest first
Class II · Moderate risk
BUPIVAcaine HCL Sterile injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk
fentaNYL Citrate PF 200 mcg/100 mL
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL Citrate PF 200 mcg/100 mL
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 500 mcg/100 mL
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 500 mcg/100 mL
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 100 mcg/50 mL
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 200 mcg/100 mL
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 200 mcg/100 mL
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium…
Lack of assurance of sterility:
Class II · Moderate risk
fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride
Lack of assurance of sterility:
Class II · Moderate risk
fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium…
Lack of assurance of sterility:
Class II · Moderate risk
FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag
cGMP deviations: due to shipment of rejected units.
Class II · Moderate risk
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium…
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
Sensorcaine-MPF
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Class II · Moderate risk
Sensorcaine
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Class II · Moderate risk
Sensorcaine
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Class II · Moderate risk
PF-0.125% Bupivacaine HCl Injection
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class III · Low risk
Zynrelef (bupivacaine and meloxicam)
Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
Class II · Moderate risk
Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for…
Lack of Assurance of Sterility
Class II · Moderate risk
Bupivacaine HCl 150 mg
Lack of Assurance of Sterility
Class II · Moderate risk
0.125% Bupivacaine HCl Injection
Lack of Assurance of Sterility
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