Asclemed USA Inc.: Accucaine, Kit

Accucaine Kit Recall Summary Asclemed USA Inc. is recalling Accucaine Kit, a lidocaine injection product used for local anesthesia, distributed nationwide because the manufacturer cannot confirm the product is sterile. The recall is classified as Class II, meaning the product could cause serious health problems or temporary adverse effects, though it is unlikely to cause death. The affected product is the 1% lidocaine solution in 5 mL ampules distributed by Enovachem Pharmaceuticals.

Recalling firm

Asclemed USA Inc.

Product

Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-715-01.

Reason

Lack of Assurance of Sterility

Classification

Class II

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-06-08

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

USA Nationwide

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/fc9d7190-4e07-4605-a4ae-1ecd6cfd557d