D-0658-2026 Class II Ongoing

Recalled by Asclemed USA Inc. — Torrance, CA

FDA drug recall D-0658-2026 was initiated by Asclemed USA Inc. on June 8, 2026 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: N/A.

Recall Details

Product Type
Drugs
Report Date
July 8, 2026
Initiation Date
June 8, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

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 for Recall

Lack of Assurance of Sterility

Distribution Pattern

USA Nationwide

Code Information

Lot #: AE3102, 121924X2, 022525X4, 033125X1, 030426X2, 033125X2, 041725X3, 061225X1, 072225X3, 080525X6, 080525X7, 080525X8, 091225X1, 100225X2, 100625X1, 122225X4, 010626X3, 041326X4, Exp 11/30/2026; AE5052, 041426X2, 041726X1, 051826X2, Exp 04/30/2028.