FDA-Drug2026-07-08Class IIPROCESSING DEFECT
Asclemed Lidocaine HCl Injection recalled for lack of sterility assurance
What this means
Asclemed USA Inc. is recalling Lidocaine HCl Injection USP 1% in 5 mL single-dose ampules due to lack of assurance of sterility. The affected lots were distributed nationwide. This is a precautionary measure to prevent potential infection risk from non-sterile product.
- Check your facility's inventory for the affected lot numbers: AE3102 (031926L01, 032026A01, Exp 11/30/2026) and AE5052 (052026G01, Exp 04/30/2028).
- Do not use affected ampules. Quarantine and return them to your distributor or contact Enovachem Pharmaceuticals.
- Notify your patients or healthcare team if this product was recently administered.
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
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0659-2026More Asclemed USA Inc. recalls
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