Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose… recall
FDA recall D-0658-2026 · initiated Jun 8, 2026
Asclemed USA Inc. recalled Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL… in Jun 2026 — an FDA Class II recall (D-0658-2026) 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
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: N/A
Details
- Product
- 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.
- 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 Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL… recalled?
- Asclemed USA Inc. recalled Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL… in Jun 2026 — an FDA Class II recall (D-0658-2026) because Lack of Assurance of Sterility. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL… recalled?
- Per the FDA enforcement record, the reason for recall D-0658-2026 was: Lack of Assurance of Sterility
- Is a recalled Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL… 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 Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL… are affected?
- Distributed: USA Nationwide. The recall covers these 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.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0658-2026.