Class II · Moderate risk
Lidocaine Hydrochloride
Superpotent Drug: Minimally superpotent
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 I · High risk
Lidocaine Hydrochloride
Superpotent Drug
Class II · Moderate risk
Lidocaine Hydrochloride Topical Solution USP 4%
CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
Class I · High risk
Lidocaine Hydrochloride Topical Solution USP 4%
Superpotent Drug
Class II · Moderate risk
Lidocaine Hydrochloride Topical Solution USP 4%
CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
Class II · Moderate risk
Goal-Glutamine 75mg/Ornithine 75mg/Arginine 150mg/Lysine…
Lack of assurance of sterility
Class II · Moderate risk
B Complex Inj Cmp-No B12
Lack of assurance of sterility
Class I · High risk
Lidocaine Hydrochloride Topical Solution
Superpotent Drug
Class III · Low risk
Lidocaine Ointment USP
Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.
Class II · Moderate risk
Xylocaine-MPF with Epinephrine 1:200
Low out of specification results for epinephrine assay.
Class I · High risk
1% Lidocaine HCl 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 III · Low risk
Lidocaine Ointment USP
Failed Stability Specifications: product did not meet viscosity results.
Class II · Moderate risk
Lidocaine HCL Visc 2% 100ml
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Lidocaine/Tetracaine
Superpotent Drug. Lidocaine higher concentration than listed
Class III · Low risk
Epinephrine/Lidocaine HCl
Labeling: Incorrect or Missing Lot and/or Exp Date
Class II · Moderate risk
Lidocaine HCl 2% 5 mL
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
Lidocaine HCl 1% 10 mL
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
Buffered Lidocaine HCl
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I · High risk
Regenecare Ha
Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
Class II · Moderate risk
Ear Pain MD Pain Relief Drops with 4% Lidocaine
cGMP Deviations.
Class II · Moderate risk
Ear Pain MD Pain Relief Drops For Kids
cGMP Deviations.
Class II · Moderate risk
Lidocaine Patch 5%
Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.
Class II · Moderate risk
Lidothol Patch
CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.
Class II · Moderate risk
Maximum Strength Lidocaine Cold & Hot Patch
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Class II · Moderate risk
Mencaine (lidocaine 4.5%, menthol 5%)
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
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