Class II · Moderate risk
Fentanyl Citrate and Bupivacaine HCl and Morphine Sulfate in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
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
Bupivacaine HCl and Hydromorphone HCl in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL and…
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Fentanyl 2mcg/Ml Bupivacaine 0.125% in Nacl 0.9% Sry C-Ii
Lack of Assurance of Sterility
Class II · Moderate risk
Heparin 10
Lack of sterility assurance.
Class II · Moderate risk
Fentanyl (as citrate)
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
fentaNYL 3 mcg/mL
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
Fentanyl Citrate and Bupivacaine HCl in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Bupivacaine HCl in 0.9% Sodium Chloride in all doses
Lack of sterility assurance.
Class II · Moderate risk
fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125%
Lack Of Assurance Of Sterility.
Class II · Moderate risk
HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride 50 mL
Lack Of Assurance Of Sterility.
Class II · Moderate risk
fentaNYL 3 mcg/mL + BUPIvacaine 0.1% in 0.9% Sodium Chloride 250 mL
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
fentaNYL 2 mcg/mL + BUPIvacaine 0.125% PF in 0.9% Sodium Chloride 250 mL
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
fentaNYL 2 mcg/mL + BUPIvacaine 0.1% PF in 0.9% NS 250 mL
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
fentaNYL 2 mcg/mL+Bupivacaine 0.0625% PF in 0.9% Sodium Chloride 250 mL
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
BUPIVacaine HCl 0.2% IN 0.9% Sodium Chloride 250 mL Bag Preservative Free
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
BUPIVacaine HCl 0.125% In 250 mL 0.9% Sodium Chloride Bag
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
BUPIVacaine HCl 0.1% PF
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
Fentanyl Citrate and Bupivacaine HCl all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Bupivacaine 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
Bupivacaine HCl 0.25% 400 mL Total Volume in an ON-Q Pump in 0.9%…
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Bupivacaine HCl 0.25% 270 mL Total Volume in an ON-Q Pump in 0.9%…
Labeling: Incorrect or Missing Lot and/or Exp Date
Class II · Moderate risk
Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Marcaine 0.5%
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.