Class I · High risk
Bupivacaine Hcl-Baclofen Pf Injectable 40mg-4000mcg/Ml
Non-Sterility
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
Triamcinolone Acetonide/Bupivacaine Hydrochloride Injectable Suspension
Lack of Assurance of Sterility
Class II · Moderate risk
Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension
Lack of Assurance of Sterility
Class II · Moderate risk
Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL 800 mcg/200 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 200 mcg/100 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 200 mcg/100 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 200 mcg/100 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 200 mcg/100 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 500 mcg/250 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 500 mcg/250 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 500 mcg/250 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9%…
GMP Deviations: potential glass contamination
Class II · Moderate risk
PF-Fentanyl Citrate
GMP Deviations: potential glass contamination
Class II · Moderate risk
LIDOcaine 2%
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine 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
Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine…
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Fentanyl Citrate and Bupivacaine HCL and Clonidine 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 Citrate and Bupivacaine HCL and Clonidine HCL and Baclofen 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
Morphine Sulfate and Bupivacaine HCL and Baclofen and Clonidine 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
Morphine Sulfate and Bupivacaine HCL and Clonidine 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
Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF 500 mcg/mL/Bupivacaine HCL PF 12.8 mg/mL
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Clonidine HCL PF 750 mcg/mL/Prialt PF
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Morphine Sulfate and Bupivacaine 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
Hydromorphone HCL and Bupivacaine HCL in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
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