FDA-Drug2026-07-08Class IIPROCESSING DEFECT
Accucaine lidocaine injection recalled for lack of sterility assurance
What this means
Asclemed USA Inc. is recalling specific lots of Accucaine, a lidocaine injection used for local anesthesia, because the manufacturer cannot guarantee the product is sterile. This affects multiple lot numbers distributed nationwide.
- Check the lot number on your Accucaine ampule against the recall list
- Do not use affected lots; contact your pharmacy or healthcare provider
- Return unused product to the pharmacy or manufacturer
The agency's original wording
Hazard
Lack of Assurance of Sterility
Intended for
Adults
Illnesses reported
None reported
Sold states
USA Nationwide
Affected count
N/A
Manufactured in
379 Van Ness Ave Ste 1403, N/A, Torrance, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0658-2026More Asclemed USA Inc. recalls
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