FDA recalls Omega Nutrition's Ortiga mas Ajo Rey Reforzado with Omega 3, 6 & 9 due to undeclared diclofenac. Products sold in Mexico with specific lot numbers may pose health risks.
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
The FDA has recalled Omega Nutrition's Ortiga mas Ajo Rey Reforzado product because lab tests found it contains diclofenac without proper approval. This undeclared ingredient could cause health issues if taken.
The product was found to contain diclofenac, a painkiller, without proper FDA approval. This means the product was marketed as safe but contains an ingredient that could cause health problems if taken.
People who purchased the product from Amazon.com in Mexico with lot number 040 19 and expiration date February 2025 are affected. Those who have taken the product may be at risk due to the undeclared diclofenac.
Check for the product name 'Ortiga mas Ajo Rey Reforzado con Omega 3, 6 y 9' in cartons with 30 tablets (500 mg) and 60 capsules (400 mg). Look for lot number 040 19 and expiration date February 2025 on the packaging.
Verify the product has lot number 040 19 and expiration date February 2025.
FDA lab tests found the product contains undeclared diclofenac, which was not approved for use in the US.
The recall record does not specify a remedy.
Check the product details for lot number 040 19 and expiration date February 2025. If you have the product, you may want to contact the manufacturer for guidance.
We’ve drafted a message you can send Omega Nutrition to request your refund or repair — edit it as you like.
Subject: Recall D-1296-2022 — Omega Nutrition Omega Nutrition Hello, I own a Omega Nutrition that is covered by recall D-1296-2022 from Omega Nutrition. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
