Class IIOngoing
Lidocaine HCl Injection USP recall
FDA recall D-0659-2026 · initiated Jun 8, 2026
By the pharmaranks editorial teamReviewed against the FDA (openFDA) sourcesUpdated Jul 8, 2026How we research
Asclemed USA Inc. recalled Lidocaine HCl Injection USP in Jun 2026 — an FDA Class II recall (D-0659-2026) because Lack of Assurance of Sterility.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility
Details
- Product
- 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.
- Recalling company
- Asclemed USA Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- Jun 8, 2026
- FDA report date
- Jul 8, 2026
Frequently asked
- Was Lidocaine HCl Injection USP recalled?
- Asclemed USA Inc. recalled Lidocaine HCl Injection USP in Jun 2026 — an FDA Class II recall (D-0659-2026) because Lack of Assurance of Sterility. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Lidocaine HCl Injection USP recalled?
- Per the FDA enforcement record, the reason for recall D-0659-2026 was: Lack of Assurance of Sterility
- Is a recalled Lidocaine HCl Injection USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Lidocaine HCl Injection USP are affected?
- Distribution: USA Nationwide. The affected lot numbers and expiration dates are listed in the official FDA enforcement record for recall D-0659-2026, initiated Jun 2026.