Class II · Moderate risk
Lidocaine gel 1%
Lack of sterility assurance.
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/Epinepherine liquid 1%/ 1:1000
Lack of sterility assurance.
Class II · Moderate risk
Lidocaine gel 2%
Lack of sterility assurance.
Class II · Moderate risk
0.9% Buffered Lidocaine HCl
Subpotent
Class II · Moderate risk
ICB-Complex
Lack of sterility assurance.
Class II · Moderate risk
Amino Blend Injection
Lack of sterility assurance.
Class II · Moderate risk
Lidocaine 1% + Epinephrine 1:100
Subpotent drug: During testing of the retention sample, the firm discovered that the product was sub-potent.
Class II · Moderate risk
Trimix Papaverine/Phentolamine/Alprostadil/Lidocaine 30 mg/1…
Lack of Assurance of Sterility
Class II · Moderate risk
Glycerin 72%
Lack of Assurance of Sterility
Class II · Moderate risk
Bi-Mix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Bi-Mix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Bi-Mix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine 2.5% and Prilocaine Cream
Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.
Class II · Moderate risk
Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use
Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding.
Class II · Moderate risk
Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes…
Lack of sterility assurance.
Class III · Low risk
Lidocaine Patch 5%
Failed Stability Specifications
Class II · Moderate risk
Lidocaine USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
Lidocaine HCl USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class III · Low risk
BonaDur For Men
CGMP Deviations: not manufactured according to current good manufacturing practices.
Class II · Moderate risk
Lidocaine HCl in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Lidocaine HCl in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Benzocaine 20%
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Benzocaine 20%
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine
GMP Deviations: inadequate manufacturing control processes
Class II · Moderate risk
Extra Strength Naturally HL Liquid Hemorrhoid Relief Gel
GMP Deviations: inadequate manufacturing control processes
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