HIGHFDA DRUG

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.

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
June 8, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
June 8, 2026
Hazard Level
HIGH
Brands
ACCUCAINE, Asclemed USA, Inc.
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
ACCUCAINE, Asclemed USA, Inc.
Model numbers
Lot #: AE3102, 121924X2, 022525X4, 033125X1, 030426X2, 033125X2, 041725X3, 061225X1 +12 more
UPC codes
76420-715, 76420-715-01
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    June 8, 2026

  2. Reported by FDA DRUG

    July 8, 2026

  3. RecallRadar source check

    July 14, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Lack of Assurance of Sterility

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Asclemed USA Inc. or your healthcare provider for guidance. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

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Full Description

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.. Generic: LIDOCAINE HYDROCHLORIDE; Brand: ACCUCAINE. Reason: Lack of Assurance of Sterility. Classification: Class II. Quantity: N/A. Distribution: USA Nationwide

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
Lot #: AE3102
121924X2
022525X4
033125X1
030426X2
+15 more
UPC Codes
76420-715
76420-715-01
Affected States
ALL
Report Date
July 8, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE