Class II · Moderate risk
0.05 mg/mL Morphine Sulfate and 0.0625% Bupivacaine HCI
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Is Bupivacaine recalled?
Yes — there is an active recall. 5 ongoing FDA recalls mention Bupivacaine (306 total). Check the affected lots below.
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 on record
none so far in 2026; 306 on record, newest first
Class II · Moderate risk
0.03% Bupivacaine HCl
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Class II · Moderate risk
Sensorcaine- MPF
Presence of Particulate Matter: Glass particulate found in sterile injectable product
Class II · Moderate risk
Sufentanil Citrate 0.4mcg/mL & Bupivacaine 0.1% in 0.9% Sodium…
Lack of Assurance of Sterility
Class II · Moderate risk
Bupivacaine HCI 0.25% in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Bupivacaine HCI 0.125% in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Fentanyl Citrate 2 mcg/mL & Bupivacaine HCL 0.125 % in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Fentanyl Citrate 5 mcg/mL & Bupivacaine 0.06% in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Fentanyl Citrate 2.5 mcg/mL & Bupivacaine 0.075% in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Bupivacaine HCI 0.125% 50 mL fill in a 60 mL syringe
Lack of Assurance of Sterility
Class II · Moderate risk
Fentanyl Citrate 2mcg/mL & Bupivacaine 0.125% in 0.9% Sodium Chloride 150 mL Intravia bag
Lack of Assurance of Sterility
Class II · Moderate risk
Bupivacaine 1mg/mL injection in 0.9% Sodium Chloride 250 mL bag
Lack of Assurance of Sterility
Class II · Moderate risk
Sufentanil Cit 50 mcg/ml/Clonidine HCL 1 mcg/ml/Bupivacaine HCL 5 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 7 mg/ml/Bupivacaine HCL 11.2 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 4 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 25 mg/ml/Bupivacaine HCL 4 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Fentanyl Citrate 1.275 mg/ml/Baclofen 150 mcg/ml/Bupivacaine HCL…
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 20 mg/ml/Bupivacaine HCL 40 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 30 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 50 mg/ml/Bupivacaine HCL 24 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 20 mg/ml/Bupivacaine HCL 11.3 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 9 mg/ml/Sufentanil Cit 180 mcg/ml/Bupivacaine HCL 33 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 10 mg/ml/Baclofen 460 mcg/ml/Bupivacaine HCL
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 6 mg/ml/Bupivacaine HCL 32 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Bupivacaine
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
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