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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

AvKARE Sodium Fluoride Toothpaste Recalled for Mix-up with Capsaicin Cream

Agency Publication Date: September 7, 2023
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Summary

AvKARE LLC is recalling 70,368 units of Sodium Fluoride 1.1% Prescription Dental Toothpaste and Capsaicin Cream 0.025% due to a product mix-up. Some cartons labeled as Capsaicin Cream may actually contain tubes of the prescription dental toothpaste. The toothpaste is a 1.8-ounce tube of spearmint flavored fluoride (5000 ppm), while the intended cream is a 2.1-ounce topical pain reliever.

Risk

A product mix-up could lead to consumers using the wrong medication for their intended treatment. If prescription toothpaste is applied topically to the skin as if it were pain cream, or if the mix-up causes confusion about proper usage, it could lead to ineffective treatment or localized irritation. No injuries have been reported to date.

What You Should Do

  1. This recall affects AvKARE brand Sodium Fluoride 1.1% Prescription Dental Toothpaste (NDC 42291-741-51) and Capsaicin Cream 0.025% (NDC 50268-195-60) sold in Pulaski, TN and distributed to various pharmacies.
  2. Check your product packaging for lot number P23025 (Exp. 02/24/2025) on the toothpaste tube or lot number P22078 (Exp. 11/30/2024) on the capsaicin cream carton.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information regarding this recall.

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: Sodium Fluoride 1.1% Prescription Dental Toothpaste (1.8 oz)
Variants: Spearmint, 5000 ppm Fluoride
Lot Numbers:
P23025 (Exp. 02/24/2025)
NDC:
42291-741-51

Recall #: D-1146-2023. Quantity: 35,184 tubes.

Product: Capsaicin Cream 0.025% External Analgesic (2.1 oz)
Variants: Cream, 0.025% Strength
Lot Numbers:
P22078 (Exp. 11/30/2024)
NDC:
50268-195-60

Recall #: D-1147-2023. Quantity: 35,184 cartons.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92868
Status: Resolved
Manufacturer: AVKARE LLC
Sold By: pharmacies; consignees
Manufactured In: United States
Units Affected: 2 products (35,184 tubes; 35,184 cartons)
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.