CLASS IIDrug recall · Reported 2 Feb 2022 · FDA Enforcement Report
Lidocaine HCl Sterile Buffered Solution for Injection recalled
Edge Pharma is recalling Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1% per syringe, Single Use, distributed nationwide in the US. The recall was initiated on 6 Dec 2021 and the FDA has classified it as Class II.
Check your package
Lot, batch or date codes08-2021-27@3 12/09/2021 09-2021-24@1 01/06/2022 10-2021-14@2 01/31/2022
Quantity recalled4465 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.
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 Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syringe for Infiltration and Nerve Block, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0850-10
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.