Class II · Moderate risk
Bupivacaine HCl Inj. USP
Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial.
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 3%
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
Class I · High risk
Marcaine (bupivacaine HCl)
Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.
Class II · Moderate risk
0.5% Bupivacaine HCl and Epinephrine 1:200
Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
Class II · Moderate risk
0.5% Bupivacaine HCl and Epinephrine 1:200
Lack of Assurance of Sterility; potential for vial breakage
Class I · High risk
0.75% Bupivacaine HCl Injection
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
Class I · High risk
0.25% Bupivacaine HCl Injection
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
Class II · Moderate risk
Baclofen/Bupivacaine 2
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class I · High risk
Class II · Moderate risk
Methylprednisolone and Bupivacaine Injection
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Class II · Moderate risk
Bupivacaine Injection
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Class II · Moderate risk
Bupivacaine and Dexamethasone Injection
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Class II · Moderate risk
Betamethasone Combination with Lidocaine 1% and Bupivacaine 0.5 % Injection
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Class II · Moderate risk
EXPAREL (bupivacaine liposome injectable suspension)
Subpotent; bupivacaine
Class II · Moderate risk
Bupivacaine 0.25% PF
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone/Baclofen/Bupivacaine
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk
Dmso / Bupivacaine HCL 50%/0.5% Injectable 100 Ml
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk
Bupivacaine/Sufentanil
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk
Bupivacaine/Morphine Sulfate
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk
Bupivacaine/Lidocaine/Methylprednisolone 0.17% / 0.67% / 2.7% Injectable 15 Ml
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk
Bupivacaine/Lidocaine 0.11% / 0.44% Injectable 150 Ml
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk
Bupivacaine/Hydromorphone
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk
Bupivacaine/Fentanyl in Sodium Chloride 0.9% P. F. 30 Mg/200 Mcg/Ml Intrathecal 40 Ml
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk
Bupivacaine/Clonidine/Morphine/Ziconotide
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk
Bupivacaine/Clonidine/Morphine
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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