Injectable Lidocaine Syringes Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center has recalled 1,380 prefilled lidocaine syringes nationwide due to inability to confirm product sterility.
What this means for you
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 Class II recall of injectable medication with unconfirmed sterility. No illnesses reported, but non-sterile injectables carry direct risk of serious infection, meeting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling 1,380 prefilled syringes of 0.9% Buffered Lidocaine HCl injectable solution (9 mg/mL per 5 mL syringe). The affected product is lot BL2007A with an expiration date of July 3, 2022. This product was distributed nationwide in the United States.
The recall is due to lack of assurance of sterility. The manufacturer was unable to verify that the product met sterility requirements for injectable medications. Sterility is a critical requirement for any product intended for injection.
This is a Class II recall issued by the U.S. Food and Drug Administration. The risk associated with non-sterile injectable medications is serious infection. Healthcare providers and patients who may have received or been administered this product should be aware of the recall status.
The recalled product
- Product
- 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate), 45 mg/5 mL (9 mg/mL) syringes, packaged in 5 x 5 mL Prefilled 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:
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Injectable Anesthetic
- Affected units
- 1,380
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)
- Lots: BL2007A
- Exp. 7/3/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 37 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 37 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 · lack of sterility
See all →- HighRohto Cooling Eye Drops Max Strength Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighRohto Cooling Eye Drops Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2026-07-29
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-15
- SevereAzacitidine for Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15