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Drug FDA Class II Ongoing Mislabeling

AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,

C & A Naturistics Published Oct 30, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact C & A Naturistics or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.

Hazards

Undeclared Diclofenac · primaryUndeclared Acetaminophen

Affected products (1)

AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,

Unknown

Code info: All Lots

Affected areas

Nationwide

Timeline

  1. Initiated
    Oct 8, 2024
  2. Published
    Oct 30, 2024
Recall number
D-0024-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.