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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/Dietary Supplements

AK Forte Ortiga y Omega 3 Recalled for Undeclared Diclofenac and Acetaminophen

Agency Publication Date: October 22, 2024
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Summary

C & A Naturistics is recalling all lots of AK Forte Ortiga y Omega 3 dietary supplement tablets (400 mg). FDA testing discovered that the product is tainted with undeclared diclofenac and acetaminophen, which are pharmaceutical drug ingredients not listed on the label. This product was marketed as a supplement without an approved drug application.

Risk

Undeclared diclofenac and acetaminophen can cause serious health risks including stomach bleeding, liver damage, and severe allergic reactions. These risks are significantly increased if consumers unknowingly take this product alongside other medications containing the same active ingredients.

What You Should Do

  1. The recalled product is AK Forte Ortiga y Omega 3 dietary supplement, sold in 100-tablet containers (400 mg per tablet). All lots and expiration dates are affected.
  2. 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 C & A Naturistics for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

💰Option 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
🗑️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: AK Forte Ortiga y Omega 3 (100 Tabletas)
Variants: 400 mg, Tablets
Lot Numbers:
All Lots

Marketed as a dietary supplement; contains undeclared drug ingredients.

Product Images

“AK Forte Con Ortiga y Omega 3, 100 tabletas”

“AK Forte Con Ortiga y Omega 3, 100 tabletas”

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95520
Status: Active
Manufacturer: C & A Naturistics
Sold By: Authorized retailers nationwide
Manufactured In: United States
Units Affected: Unknown
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 · FDA Press Release · 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.