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FDAClass II · Drug · Recalled July 8, 2026
Accucaine 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-0658-2026
- Brand
- Asclemed USA
- Classification
- Class II
- Units affected
- N/A
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
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.
Affected products
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, 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.
- 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 23, 2026 at 11:04 PM UTC.
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