Recall: D-0658-2026

Class II - Potentially Harmful

Class IIClassification

2026-06-08Initiated

OngoingStatus

Asclemed USA Inc.Firm

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

Distribution

USA Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.