Class II · Moderate risk
Theracare Maximum Strength Pain Relief 4% Lidocaine Patch
cGMP Deviations
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
Lidocaine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCL Injection
Subpotent Drug: reduced efficacy for epinephrine
Class II · Moderate risk
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL…
Lack of Assurance of Sterility
Class II · Moderate risk
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL…
Lack of Assurance of Sterility
Class III · Low risk
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free
Out of specification for assay
Class I · High risk
Alcoholada Gel
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Class II · Moderate risk
Lidocaine HCL 1%
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class II · Moderate risk
Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS
CGMP Deviations
Class III · Low risk
LET Gel
Product Mix-up: Incorrect Product Formulation
Class III · Low risk
Epinephrine-Lidocaine HCl
Subpotent: Failing Test Results for Epinephrine
Class I · High risk
2% Lidocaine HCl Injection
Presence of Particulate Matter: identified as glass.
Class I · High risk
1% Lidocaine HCl Injection
Presence of Particulate Matter: identified as glass.
Class II · Moderate risk
Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCl 4% ophthalmic solution
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial
Lack of Assurance of Sterility
Class II · Moderate risk
lidocaine 2%
Lack of assurance of sterility:
Class II · Moderate risk
Cardioplegia Solution del Nido Formula
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
lidocaine 2%
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
Cardioplegia Solution del Nido Formula
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
Lidocaine 2% HCl Inj
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
Lidocaine Hydrochloride Oral Topical Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Lidocaine HCl Jelly USP
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Lidocaine Ointment USP
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Lidocaine 2.5% & Prilocaine 2.5% Cream
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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