Class II · Moderate risk
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 Hydrochloride
cGMP deviations: Temperature abuse
Class II · Moderate risk
Bupivacaine HCl Injection
cGMP deviations: Temperature abuse
Class II · Moderate risk
Bupivacaine HCl Injection
cGMP deviations: Temperature abuse
Class II · Moderate risk
Bupivacaine HCl Injection
cGMP deviations: Temperature abuse
Class II · Moderate risk
Bupivacaine HCl Injection
cGMP deviations: Temperature abuse
Class II · Moderate risk
Bupivacaine HCl Injection
cGMP deviations: Temperature abuse
Class II · Moderate risk
Lidocaine HCL / Bupivacaine HCL
Lack of Assurance of Sterility
Class I · High risk
0.5% Bupivacaine Hydrochloride Injection
Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
Class II · Moderate risk
fentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
Sensorcaine-MPF
Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
Class II · Moderate risk
Bupivacaine Hydrochloride in 8.25% Dextrose Injection
Presence of particulate matter in solution - black and transparent particles
Class I · High risk
Class I · High risk
Hydromorphone Hcl-Bupivacaine Hcl-Sufentanil Pf…
Non-Sterility
Class I · High risk
Class I · High risk
Class I · High risk
Class I · High risk
Class I · High risk
Class I · High risk
MORPHINE-BUPIVACAINE PF INJECTABLE 21 mL
Non-Sterility
Class I · High risk
Class I · High risk
Class I · High risk
Class I · High risk
Fentanyl-Bupivacaine HCL Pf Injectable 3000mcg-12mg/Ml
Non-Sterility
Class I · High risk
Bupivacaine Hcl-Lioresal Pf Injectable 7.5mg-1625mcg/Ml
Non-Sterility
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