Class III · Low risk
Lidocaine Patch 5%
Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.
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
Maximum Zone2 Topical Analgesic
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Class II · Moderate risk
New & Improved Blue Gel Anesthetic
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Class I · High risk
Easy Care first aid Burn Cream
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Class II · Moderate risk
Lidocaine-Pf- 5%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Glycerin/Lidocaine Hcl/Epinephrine 31%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
BSS Plus/Lidocaine Opth 1%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Epi-Caine
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class II · Moderate risk
Lidocaine Hydrochloride Jelly USP
CGMP Deviations:
Class II · Moderate risk
LIDOCAINE EPINEPHRINE BUFFERED 2%/1:1000 Solution
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
LIDOCAINE/PHENYLEPHRINE PF SYR 1%/1.5% Solution
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
Lidocaine Hydrochloride Jelly USP
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Class II · Moderate risk
Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for…
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
0.9% Buffered Lidocaine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
Aspercreme With Lidocaine Creme 1.75 Oz Sku 999852 Icy Hot…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
LIDOCAINE ARTHRITIS AND SPORT WNTGRN 16 FLOZ distributed to…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Lidocaine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine 1%/Epinephrine 1:100
Lack of assurance of sterility.
Class II · Moderate risk
Lidocaine 2%
Lack of assurance of sterility.
Class II · Moderate risk
Lidocaine Prilocaine Cream USP
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Class II · Moderate risk
Lidocaine Hydrochloride Topical Solution USP 4%
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Class III · Low risk
Lidocaine Hydrochloride Oral Topical Solution
Failed viscosity specification - product was below specificcation
Class II · Moderate risk
Lidocaine 2.5% and Prilocaine 2.5% Cream
cGMP Deviations
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