Class II · Moderate risk
PRE-TAT (lidocaine)
Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.
Is Lidocaine recalled?
Yes — there is an active recall. 61 ongoing FDA recalls mention Lidocaine (366 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Lidocaine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Lidocaine recalls on record
none so far in 2026; 366 on record, newest first
Class II · Moderate risk
Workvie Instant Pain Relieving Roll On
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
Lid O Creme
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
Lido E.R. (Lidocaine HCL 4%)
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
LidoAID (Lidocaine HCL 4%)
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
LIDOCAINE 0.75%/Epinephrine 0.025%/BSS 0.56ML SYR
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCL 2% Injection Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCL 1% Injection Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Buffered Lidocaine HCL 1% Injection Sol
Lack of Assurance of Sterility
Class II · Moderate risk
Buffered Lidocaine HCL 1% Injection Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Buffered Lidocaine 1%+epi 1:100
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine 0.5%/Phenylephrine 0.75% P.F. INJ
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Class II · Moderate risk
DelNido Cardioplegia
Lack of sterility assurance.
Class II · Moderate risk
Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1
Lack of sterility assurance.
Class II · Moderate risk
Lidocaine 1% - Sodium Bicarb 8.4% 10:1
Lack of sterility assurance.
Class II · Moderate risk
Lidocaine Buffered with J-Tip 0.25 mL
Lack of sterility assurance.
Class II · Moderate risk
Lidocaine 1%/Dextrose 12.5%
Lack of sterility assurance.
Class II · Moderate risk
Heparin 2 mL/Lidocaine 2%-10 mL/Sodium Bicarbonate 8.4%-5mL/ Sterile Water 10 mL
Lack of sterility assurance.
Class II · Moderate risk
Heparin 20
Lack of sterility assurance.
Class I · High risk
Lidocaine HCl Injection
Presence of Particulate Matter: One vial was found to contain a hair.
Class II · Moderate risk
2% Lidocaine HCl Injectable Solution
Lack of Assurance of Sterility
Class II · Moderate risk
2% Lidocaine HCl Injectable Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Pge1-Lidocaine 40 Mcg-1% /Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
LET Gel 4%
Labeling: Incorrect or Missing Lot and/or Exp Date: Labels are missing lot and expiration date and are printed as Lot# YYYDDYY@XX with a Beyond Use Date: MM/DD/YYY.
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