Asclemed Accucaine 1% Lidocaine Injection Recall: Lack of Sterility Assurance
Asclemed recalls Accucaine 1% Lidocaine injection due to lack of sterility assurance. This may cause infections if used improperly. Contact the manufacturer for details.
Lower-risk recall
Lack of Assurance of Sterility
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What happened, in plain English
Asclemed is recalling Accucaine, a 1% lidocaine injection for medical use, because it may not be sterile. This could lead to infections if the product is used. Read more at govinfonow.com/recall/31212-asclemed-accucaine-1-lidocaine-injection-recall-lack-of-sterility-assurance.
Source Summary by GovInfoNow · govinfonow.com/recall/31212-asclemed-accucaine-1-lidocaine-injection-recall-lack-of-sterility-assurance · Updated August 10, 2026 · FDA enforcement record: FDA #D-0658-2026
Cite this page
“Asclemed Accucaine 1% Lidocaine Injection Recall: Lack of Sterility Assurance.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/31212-asclemed-accucaine-1-lidocaine-injection-recall-lack-of-sterility-assurance. Based on FDA recall #D-0658-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0658-2026%22&limit=1).
Why it’s dangerous
The product lacks assurance of sterility, meaning it might contain contaminants that could cause infections when injected. This is a risk during medical procedures where sterile conditions are critical.
Who’s affected
Healthcare professionals and patients who have the Accucaine kit with the specified lot numbers. Those using the product for medical procedures are most at risk.
How to tell if you have this one
Check the product label for the lot numbers listed: 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.
- Brand
Asclemed- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
USA Nationwide
| Recall number | Product, codes & lots | NDC |
|---|---|---|
| D-0658-2026 | 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.; 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. | 76420-715-01 |
| D-0659-2026 | 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.; Lot #: AE3102, 031926L01, 032026A01, Exp 11/30/2026; AE5052, 052026G01, Exp 04/30/2028. | 85766-187-01, 85766-187-25 |
What to do — step by step
Check Product Label
Look for the lot numbers listed in the recall notice to determine if your product is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 30 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0658-2026 (June 8, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0658-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.