FDAClass II · Drug · Recalled July 8, 2026

Lidocaine HCl Injection USP recall — Asclemed USA Inc.

Hazard: Lack of Assurance of Sterility

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0659-2026
Brand: Asclemed USA
Classification: Class II
Units affected: N/A
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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.

Affected products

Lidocaine HCl Injection USP

Companies & origin

Recalling firm location: Torrance, CA, United States
Firm address: 379 Van Ness Ave Ste 1403, N/A, 90501-7211

Identifying details (verbatim from the notice)

Product codes / lots: Lot #: AE3102, 031926L01, 032026A01, Exp 11/30/2026; AE5052, 052026G01, Exp 04/30/2028.
Distribution: USA Nationwide
Firm notified the public via: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
FDA event ID: 99204
Recall initiated: June 8, 2026
FDA classified: July 2, 2026
FDA report date: July 8, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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