Lidocaine Injectable Recalled Due to Sterility Assurance Failure
Nephron Sterile Compounding Center recalled Lidocaine HCl Injection due to lack of sterility assurance. The recalled lot affects 65,590 pre-filled syringes distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA classified this as a Class II recall for a sterility assurance failure affecting injectable medication. No illnesses or injuries are reported in the source material, making this a theoretical risk-of-harm scenario. Per the rubric, theoretical hazards without reported adverse events score as High (3).
Plain-English summary
Nephron Sterile Compounding Center LLC issued a recall of Lidocaine HCl Injection, USP, 2%, in 5 mL pre-filled syringes. The recall affects lot LI2001A (expiration date 6/8/2022) distributed nationwide in the United States. The recall was initiated due to lack of assurance of sterility for the affected product.
Lidocaine HCl Injection is a local anesthetic medication used in medical and healthcare settings for infiltration and nerve blocking. Pre-filled syringes are intended for use by healthcare professionals. The affected lot consisted of 65,590 syringes.
Patients and healthcare providers should verify that any Lidocaine HCl Injection pre-filled syringes in use are not from the recalled lot. Healthcare facilities should quarantine affected product and contact Nephron Sterile Compounding Center or the FDA with any questions regarding the recall.
The recalled product
- Product
- Lidocaine HCl Injection, USP, 2%, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-FIlled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-949-05
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug
- Hazard
- Affected units
- 65,590
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: LI2001A
- Exp. 6/8/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 recalled by Nephron Sterile Compounding Center LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 20 products in this recall →Related recalls
Same manufacturer · Nephron Sterile Compounding Center LLC
See all →- HighSodium Chloride Injection Recalled for Potential Sterility Compromise
FDA (Drugs) · 2025-03-19
- HighNorepinephrine Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-03-08
- HighNephron Phenylephrine HCl Injection Recalled for Sterility Assurance
FDA (Drugs) · 2023-03-08
- HighDiltiazem HCl Injectable Drug Recalled for Sterility Assurance Failure
FDA (Drugs) · 2023-03-08
- HighFDA Recalls Norepinephrine Injection Due to Sterility Concerns
FDA (Drugs) · 2023-03-08
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- HighLidocaine HCl injection syringes recalled due to sterility assurance failure
FDA (Drugs) · 2022-07-27
- HighLidocaine HCl Injection Syringes Recalled for Sterility Assurance
FDA (Drugs) · 2022-07-27
- HighInjectable Lidocaine Syringes Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-27
- HighKetamine HCl Injection Syringes Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2022-07-27
- HighKetamine HCl Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2022-07-27
- HighLabetalol Injection Recalled Nationwide Over Sterility Assurance Defect
FDA (Drugs) · 2022-07-27