Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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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/Clonidine/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.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1471-2012
Class II · Moderate risk

Bupivacaine HCL & Epinephrine

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.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1470-2012
Class II · Moderate risk

Baclofen/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.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1460-2012
Class II · Moderate risk

Mitomycin/Bupivacaine With Epi 1:200

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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1582-2012
Class II · Moderate risk

Lidocaine/Epinephrine/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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1561-2012
Class II · Moderate risk

Lidocaine Hcl/Bupivacaine HCL Pf 1%/0.375% Ophthalmic 30 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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1559-2012