Lidocaine Hydrochloride Injection Recalled Due to the Presence of Particulate Matter

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for lidocaine hydrochloride injection, 100 mg/5 mL (20 mg/mL). The affected batch has been identified as Lot 6133801 (expires January 2028), affecting 181 225 vials.
• The recall was initiated by Fresenius Kabi USA, LLC due to the presence of particulate matter, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• Lidocaine is a local anesthetic for patients undergoing certain medical procedures.

The FDA has issued a Class II recall for lidocaine hydrochloride injections, 100 mg/5 mL (20 mg/mL), affecting 181 225 vials. This product is being recalled by Fresenius Kabi USA, LLC based in Lake Zurich, Illinois. The recall was initiated on July 16, 2026, and received a Class II classification on July 23, 2026.

A Class II recall indicates that use of or exposure to the product may cause temporary or medically reversible adverse health consequences or that the probability of serious adverse health consequences is remote.

The recall was initiated due to the presence of particulate matter; specifically, hair was identified in the product. This deficiency affects Lot 6133801, which will expire in January 2028. Fresenius Kabi USA sent out a public notice via letter. No press release has been issued for this recall.

Lidocaine hydrochloride injection is a local anesthetic that blocks nerve signals during a variety of medical and surgical procedures without causing loss of consciousness. Pharmacists should identify and quarantine Lot 6133801, remove the affected product from inventory, and work with prescribers to provide patients with an alternative supply.

Reference

FDA. Enforcement Report. July 29, 2026. Accessed July 29, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221578