Class II · Moderate risk Ongoing
Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th St, N…
Reason Lack of Assurance of Sterility
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 Ongoing
Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx only, Compounded…
Reason Subpotent Drug: reduced efficacy for epinephrine
Class II · Moderate risk Ongoing
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vial for Intraocular Injection, Imprimis…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Injection, Imprimis…
Reason Lack of Assurance of Sterility
Class III · Low risk Ongoing
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705…
Reason Out of specification for assay
Class I · High risk Ongoing
Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in (a) 8.5 fl oz (251 mL) plastic bottle UPC 0 82252…
Reason Chemical Contamination: Product manufactured with ethanol API that contains methanol
Class II · Moderate risk Ongoing
Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd…
Reason Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class II · Moderate risk Terminated
Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS
Reason CGMP Deviations
Class III · Low risk Terminated
LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel), Single-use Topical Syringe, 3mL syringe…
Reason Product Mix-up: Incorrect Product Formulation
Class III · Low risk Terminated
Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-01 Not…
Reason Subpotent: Failing Test Results for Epinephrine
Class I · High risk Terminated
2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per…
Reason Presence of Particulate Matter: identified as glass.
Class I · High risk Terminated
1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per…
Reason Presence of Particulate Matter: identified as glass.
Class II · Moderate risk Terminated
Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounded by Pine…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
lidocaine 2%, 100 mg/5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
Cardioplegia Solution del Nido Formula, Total Volume = 1,052.8 mL, EVA Bag, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium…
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
lidocaine 2%, 100 mg /5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC…
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
Cardioplegia Solution del Nido Formula, IV Bag, Total Volume = 1,052.8 mL, FOR INTRACARDIAC PERFUSION USE ONLY, PLASMA-LYTE A…
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk Terminated
Lidocaine 2% HCl Inj, 500mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC…
Reason 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 Ongoing
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only, Distributed by: Akorn Operating Company…
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL…
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY…
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class III · Low risk Ongoing
Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per carton (63629-8755-1), Rx only, each patch contains…
Reason Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each…
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.