Ortiga mas Ajo Rey supplement recalled for undeclared diclofenac
FDA recalls Ortiga mas Ajo Rey dietary supplement sold nationwide due to undeclared diclofenac. Product marketed as supplement contains pharmaceutical ingredient not listed on label.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall of product marketed without approved NDA/ANDA containing undeclared pharmaceutical ingredient (diclofenac). Per the rubric, FDA Class I recalls score minimum 4 regardless of reported illnesses.
Plain-English summary
Ortiga mas Ajo Rey Reforzado con Omega 3, 6 y 9, a dietary supplement, is being recalled nationwide. The product is packaged in cartons containing 30 tablets (500 mg) and 60 capsules (400 mg). The affected lot is #040 19 with expiration date 09 FEB 2025. Approximately 35,622 cartons were distributed in the U.S.A.
FDA laboratory analysis found the product to contain undeclared diclofenac, a nonsteroidal anti-inflammatory drug (NSAID). The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Diclofenac was not disclosed on the product label.
Consumers who have purchased this product should stop using it immediately and consult their healthcare provider if they have taken it. For questions or additional information, contact the FDA.
The recalled product
- Product
- Ortiga mas Ajo Rey Reforzado con Omega 3, 6 y 9, is packaged in a carton containing 30 tablets (500 mg c/u) in a bottle and 60 capsules (400 mg c/u) in a bottle, Hecho en Mexico por: Omega Nutrition , Jorge Washington No. 108 Col. Las Americas, Hidalgo del Parral, Chihuahua. C.P
- Manufacturer
- Amazon.com, Inc.
- Category
- Drug — Dietary Supplement
- Hazard
- undeclared-pharmaceutical
- diclofenac
- incorrect-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 040 19
- Exp. 09 FEB 2025
Distribution
Distributed nationwide across the United States.
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