Class I · High risk Ongoing
Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by…
Reason Superpotent Drug
Is Lidocaine recalled?
365 FDA recalls mention Lidocaine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Lidocaine.
Class II · Moderate risk Terminated
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310…
Reason CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals…
Class I · High risk Terminated
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310…
Reason Superpotent Drug
Class II · Moderate risk Terminated
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Manufactured by: Teligent Pharma Inc…
Reason CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals…
Class II · Moderate risk Terminated
GOAL-GLUTAMINE 75MG/ORNITHINE 75MG/ARGININE 150MG/LYSINE 150MG+LIDOCAINE 10MG/ML 75MG/75MG/150MG/150MG/10MG/ML INJECTABLE, Rx…
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
B COMPLEX INJ CMP-NO B12, NO LIDOCAINE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San…
Reason Lack of assurance of sterility
Class I · High risk Ongoing
Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only, Teligent Pharma Inc. Buena, New Jersey 08310…
Reason Superpotent Drug
Class III · Low risk Terminated
Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a laminat tube, Teligent Pharma, Inc. Buena, New Jersey…
Reason Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.
Class II · Moderate risk Terminated
Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), 30 mL…
Reason Low out of specification results for epinephrine assay.
Class I · High risk Terminated
1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose vial (NDC 0409-4279-16), packaged in 25 vials per…
Reason Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and…
Class III · Low risk Terminated
Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent Pharma Inc., Buena, New Jersey, 08310, NDC…
Reason Failed Stability Specifications: product did not meet viscosity results.
Class II · Moderate risk Terminated
LIDOCAINE HCL VISC 2% 100ML; NDC/UPC 50383077504; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS)
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Lidocaine/Tetracaine (LIPO110)* 23%/7% Ointment 100 GMS per 4 ounce plastic ointment jar, Rx Only, Stanley Specialty Pharmacy…
Reason Superpotent Drug. Lidocaine higher concentration than listed
Class III · Low risk Terminated
Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe, 0.025%/0.75%, Rx…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class II · Moderate risk Terminated
Lidocaine HCl 2% 5 mL, 20 mg/mL, Rx Only, 5 mL syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095…
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
Lidocaine HCl 1% 10 mL (10mg/ml), Rx Only, 1 mL Single Dose Syringe, SCA Pharma, Inc., 755 Rainbow Rd., Windsor, CT, 06095…
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
Buffered Lidocaine HCl, 1%, 5 mL (10mg/mL) with Sodium Bicarbonate Injection for Local Anesthetic Use, 5 mL Single Dose Syringe…
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I · High risk Terminated
REGENECARE HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel, Net Wt. 3 oz. (85 g), Manufactured For: MPM Medical Mesquite, TX…
Reason Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
Class II · Moderate risk Terminated
Ear Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South…
Reason cGMP Deviations.
Class II · Moderate risk Terminated
Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway…
Reason cGMP Deviations.
Class II · Moderate risk Terminated
Lidocaine Patch 5%, packaged in 30-count cartons, Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT…
Reason Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.
Class II · Moderate risk Terminated
Lidothol Patch, Lidocaine 4.5% & Menthol 5%, In each patch: lidocaine 4.5% topical anesthetic, menthol 5% topical analgesic, Pkg…
Reason CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.
Class II · Moderate risk Ongoing
Maximum Strength Lidocaine Cold & Hot Patch (lidocaine 4%, menthol 1%), 5 patches per box, Distributed by: CVS Pharmacy, Inc…
Reason CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain…
Class II · Moderate risk Ongoing
Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC…
Reason CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain…
Class II · Moderate risk Ongoing
LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patch, 15 Patches per box, Manufactured For: Terrain Pharmaceuticals…
Reason CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain…
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.