Class II · Moderate risk Terminated
Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include injectable medications, sterile solutions, eye drops…
Reason Lack of sterility assurance.
Is Lidocaine recalled?
Yes — there is an active recall. 60 ongoing FDA recalls mention Lidocaine (365 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.
Class II · Moderate risk Terminated
Lidocaine gel 2%, RX, plastic dropper
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 per carton, b.) 0.9% Buffered…
Reason Subpotent
Class II · Moderate risk Terminated
ICB-Complex, injection,Inositol/Choline/B1/B2/B3/B5/B6/B12/Leucine/Carnitine/Chromium/Lidocaine…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Amino Blend Injection, Ornithine/Arginine/Lysine/Lidocaine 75 mg/75 mg/75 mg/10 mg/mL 10 mL, Rx Only, Promise Pharmacy…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Lidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL, 50 mL per glass vial, Rx only, 340 West State Street, Unit 9, Athens, OH…
Reason Subpotent drug: During testing of the retention sample, the firm discovered that the product was sub-potent.
Class II · Moderate risk Terminated
Trimix Papaverine/Phentolamine/Alprostadil/Lidocaine 30 mg/1 mg/175 mcg/1 mg Powder Pharm D Solutions, Houston, Texas --- NDC…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Glycerin 72% (Lidocaine/Epi 2:1) Injectable, Pharm D Solutions, Houston, Texas ---- NDC 69699-1401-30
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Bi-Mix Injection (Alprostadil 80 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Houston, Texas --- NDC 69699-1317-03
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Bi-Mix Injection, (Alprostadil 40 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Houston, Texas --- NDC 69699-1305-03
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Bi-Mix Injection (Alprostadil 150 mcg/Lidocaine 2 mg/mL), Pharm D Solutions, Houston, Texas --- NDC 69699-1323-05
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701…
Reason Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12…
Class II · Moderate risk Terminated
Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=10 mg/mL) 0.25 mL Total Volume…
Reason Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding.
Class II · Moderate risk Terminated
Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C…
Reason Lack of sterility assurance.
Class III · Low risk Terminated
Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 patch each/ 30 Patches/Carton (NDC 0591-3525-30)
Reason Failed Stability Specifications
Class II · Moderate risk Terminated
Lidocaine USP for prescription compounding, packaged in a) 25g (NDC 58597-8019-4); b) 100g (NDC 58597-8019-6); c) 500g (NDC…
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Class II · Moderate risk Terminated
Lidocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8020-6); b) 500g (NDC 58597-8020-7); c) 1000g (NDC…
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Class III · Low risk Terminated
BonaDur For Men (lidocaine) spray, 10 mg per spray, Net Contents .25 fl. oz. (7.4 mL) spray bottles, Manufactured by WebRx…
Reason CGMP Deviations: not manufactured according to current good manufacturing practices.
Class II · Moderate risk Terminated
Lidocaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Lidocaine HCl in all strengths, all doses, and all packaging.
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Benzocaine 20%, Lidocaine 8%, Tetracaine 4% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of…
Reason 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 Terminated
Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd…
Reason 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 Terminated
Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm (NDC 69804-014-06), and 2 oz…
Reason GMP Deviations: inadequate manufacturing control processes
Class II · Moderate risk Terminated
Extra Strength Naturally HL Liquid Hemorrhoid Relief Gel, (lidocaine HCL 4%), 1/2 oz Liquid Gel (NDC 69804-024-13), 1 oz Liquid…
Reason GMP Deviations: inadequate manufacturing control processes
Class II · Moderate risk Terminated
Extra Strength Naturally HL Hemorrhoid Numbing Spray with Lidocaine, (lidocaine HCL 4%), 1/2 oz Spray (NDC 69804-015-08), 1 oz…
Reason GMP Deviations: inadequate manufacturing control processes
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