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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Topical Products

Blue Gel and Maximum Zone 2 Anesthetics Recalled for Discolored Epinephrine

Agency Publication Date: February 15, 2023
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Summary

HTO Nevada, Inc. is recalling 6,280 bottles of New & Improved Blue Gel Anesthetic and Maximum Zone 2 Topical Analgesic, which are topical numbing treatments used by licensed professionals. The recall was initiated because the epinephrine active ingredient in these products was discolored, indicating a potential quality issue with the raw materials. No injuries or adverse events have been reported to date. These products are sold in 1 oz bottles and were distributed nationwide in the U.S. and Canada by Dermal Source.

Risk

Discolored epinephrine can be a sign that the medication has degraded or been compromised, which may result in the anesthetic being less effective at reducing pain, swelling, or bleeding during procedures. While no injuries are reported, using degraded products could lead to unexpected skin reactions or treatment failure.

What You Should Do

  1. This recall affects 1 oz bottles of New & Improved Blue Gel Anesthetic (NDC 80069-008-01) and Maximum Zone 2 Topical Analgesic (NDC 80069-012-01) distributed by Dermal Source.
  2. Check your supply of New & Improved Blue Gel Anesthetic for lot numbers 796CP-0006 (Exp 02/2024) or 796CP-0007 (Exp 03/2024).
  3. Check your supply of Maximum Zone 2 Topical Analgesic for lot number 795CP-0003 (Exp 07/2024).
  4. If you have health concerns regarding a procedure where these products were used, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact HTO Nevada, Inc. at their Portland distribution office (Dermal Source) at 1-888-568-3223 or through www.dermalsource.com.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund.
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: New & Improved Blue Gel Anesthetic (1 oz bottle)by Dermal Source
Variants: Lidocaine HCL (5%), Tetracaine HCL (1%), Epinephrine (0.1%)
Lot Numbers:
796CP-0006 (Exp 02/2024)
796CP-0007 (Exp 03/2024)
NDC:
80069-008-01

Distributed by Dermal Source, Portland, OR.

Product: Maximum Zone 2 Topical Analgesic (1 oz bottle)by Dermal Source
Variants: Lidocaine HCL (5%), Epinephrine (0.01%)
Lot Numbers:
795CP-0003 (Exp 07/2024)
NDC:
80069-012-01

Distributed by Dermal Source, Portland, OR.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91694
Status: Resolved
Manufacturer: HTO Nevada, Inc.
Sold By: Dermal Source; dermalsource.com
Manufactured In: United States
Units Affected: 2 products (4709 bottles; 1,571 bottles)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.