Asclemed USA Inc.: Lidocaine Hcl Injection Usp, 1% (10 Mg/ml)

Lidocaine HCl Injection Recall Summary Asclemed USA Inc. is recalling Lidocaine HCl Injection USP, 1% (10 mg/mL) in 5 mL single-dose ampules distributed nationwide because the company cannot assure the product is sterile. This is a Class II recall, meaning use of the product could cause serious adverse health effects. The affected product was distributed by Enovachem Pharmaceuticals and is identified by NDC 85766-187-01.

Recalling firm

Asclemed USA Inc.

Product

Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 85766-187-01.

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/95f8c610-5cca-479d-8074-c7a021e9edef