CLASS II Drug recall · Reported 27 Jul 2022 · FDA Enforcement Report
Lidocaine HCl Injection, USP 1%, 50 mg/ (10 mg/mL) syringe recalled
Nephron Sterile Compounding Center is recalling Lidocaine HCl Injection, USP 1%, 50 mg/ (10 mg/mL) syringe, distributed nationwide in the US. The recall was initiated on 30 Jun 2022 and the FDA has classified it as Class II.
Check your package
Lot, batch or date codes Lots: LI2004A, Exp. 8/6/2022; LI2005A, Exp. 8/31/2022; LI2006A, Exp. 9.21.2022; LI2008A, Exp. 10/11/2022
Quantity recalled 37,310 syringes
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
Recall number D-1264-2022
FDA event ID 90512
Classification Class II
Status Terminated
Recall initiated 30 Jun 2022
FDA classified 18 Jul 2022
Reported 27 Jul 2022
Type Voluntary: Firm initiated
Customers notified by Letter
Timeline
30 Jun 2022 Recall initiated by company 18 Jul 2022 Classified by FDA +18 days 27 Jul 2022 Published in enforcement report +9 days
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Lidocaine HCl Injection, USP 1%, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-985-05
Where it was distributed
Nationwide in the USA
Nationwide
Questions about this recall
Why was it recalled? Lack of Assurance of Sterility
Which lots are affected? Lots: LI2004A, Exp. 8/6/2022; LI2005A, Exp. 8/31/2022; LI2006A, Exp. 9.21.2022; LI2008A, Exp. 10/11/2022
Where was it sold? Nationwide in the USA
What should I do if I have it? Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean? Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event 36 other products · FDA event 90512 This product is part of a recall event; the main page for the event is Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) syringe recalled .
Reported Class Recall Company Reason Where 27 Jul 2022 CLASS II Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) syringe recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II Bupivacaine HCl 150 mg (3.0 mg/mL) recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II 8.4% Sodium Bicarbonate Injection, USP (84 mg/mL) 1 mEq/mL syringe recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II Morphine Sulfate Injection, USP, 30 mg/ (1 mg/mL) syringe recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II Ketamine HCl Injection, USP, 50 mg/ (10 mg/mL*) syringes recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II Glycopyrrolate Injection, USP, 0.6 mg/ (0.2 mg/mL) syringes recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II HYDROmorphone HCl Injection, USP, 6 mg recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II Neostigmine Methylsulfate Injection, USP, 4 mg/ (1 mg/mL) syringe recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II Fentanyl Citrate in 0.9% Sodium Chloride Injection recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II Phenylephrine HCl Injection, USP, 0.4 mg/ (40 mcg/mL) syringe recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II Amino Acid Injection (50 mg/mL) recalled by Nephron Sterile Compounding Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II Morphine Sulfate Injection, USP, 1 mg/mL syringe recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II Labetalol HCl Injection, USP, 20 mg/ (5 mg/mL) syringe recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II Phenylephrine HCl Injection, USP, 1 mg/ (100 mcg/mL) syringe recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II Rocuronium Bromide Injection, 50 mg/ (10 mg/mL) syringe recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II Ketamine HCl Injection, USP 30 mg/ (10 mg/mL*) syringes recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II Neostigmine Methylsulfate Injection, USP, 5 mg/ (1 mg/mL) syringe recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II Morphine Sulfate Injection, USP, 2 mg/ (1 mg/mL) syringe recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II HYDROmorphone HCl Injection, USP 30 mg/ (1 mg/mL) syringe recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II Atropine Sulfate Injection, USP 1.2 mg/ (0.4 mg/mL) syringe recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II Morphine Sulfate Injection, USP, 50 mg/ (1 mg/mL) syringe recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II Glycopyrrolate Injection, USP, 1 mg/ (0.2 mg/mL) syringes recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II HYDROmorphone HCl Injection, USP, 50 mg/ (1 mg/mL) syringes recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II 0.125% Bupivacaine HCl Injection, USP, 62.5 mg recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II Phenylephrine HCl Injection, USP, 0.8 mg/ (80 mcg/mL)syringe recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II HYDROmorphone HCl Injection, USP, 10 mg recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II del Nido Cardioplegia Solution Single-Dose Container IV, IV recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II EPINEPHrine Injection, USP, 0.1 mg/ (10 mcg/mL) syringes recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II Lidocaine HCl Injection, USP 2%, 100 mg/ (20 mg/mL) syringe recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II Oxytocin/mL) in 0.9% Sodium Chloride Injection, USP IV recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II EPINEPHrine Injection, USP, 1 mg/ (100 mcg/mL) syringe recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II Ketamine HCl Injection, USP, 50 mg/ (50 mg/mL*) syringe recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II 0.9% Buffered Lidocaine HCl (buffered recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II Anticoagulant Sodium Citrate Solution, USP 4%, 200 mg recalled Nephron Sterile Compounding Center Sterility Nationwide 27 Jul 2022 CLASS II Neostigmine Methylsulfate Injection, USP, 3 mg/ (1 mg/mL) syringe recalled Nephron Sterile Compounding Center Sterility Nationwide
More recalls from Nephron Sterile Compounding Center All 73
Reported Class Recall Company Reason Where 29 Jul 2026 Drug CLASS II Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalled Xylocaine Fresenius Kabi USA Particulate Matter Nationwide 29 Jul 2026 Drug CLASS III Lidolog Kit, Kit Contains: Lidocaine HCl Injection recalled Lidolog Kit Asclemed USA Other TN 29 Jul 2026 Drug CLASS II Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USA Lidocaine Fresenius Kabi USA Particulate Matter Nationwide 29 Jul 2026 Drug CLASS II Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg recalled Xylocaine Fresenius Kabi USA Particulate Matter Nationwide 8 Jul 2026 Drug CLASS II Lidocaine HCl Injection USP, 1% (10 mg/mL) single dose ampule recalled Lidocaine Hydrochloride Asclemed USA Sterility Nationwide