Recall
FDAHealthJune 8, 2026

Asclemed USA Inc. — 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.

⚠️ Lack of Assurance of Sterility

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
June 8, 2026

USA Nationwide

What's affected?

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.
Lot code
AE3102

Additional details

Lot #: AE3102, 031926L01, 032026A01, Exp 11/30/2026; AE5052, 052026G01, Exp 04/30/2028.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: N/A.

View original FDA notice →

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