The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-1284-2022·Announced 2022-07-20

Arti King tablets recalled for undeclared pharmaceutical ingredients

Arti King Refozado con Ortiga y Omega 3 Tablets are recalled nationwide because FDA testing found undeclared diclofenac and dexamethasone. The product was marketed without FDA approval and should not be used.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification establishes a minimum severity of 4 (Severe). The product contains two undeclared prescription-strength pharmaceutical ingredients without proper labeling or dosing guidance, creating serious potential health risks for unknowing consumers.

Plain-English summary

Arti King Refozado con Ortiga y Omega 3 Tablets, sold in 100-count bottles, are being recalled. The product is manufactured by Latin Foods Market and produced in Mexico by PLANTAS MEDICINALES DE MEXICO. The affected lot is 334 21, with an expiration date of November 30, 2025 (UPC 7 501031 111138). The recall is nationwide in the USA.

FDA laboratory analysis found the product contains two undeclared pharmaceutical ingredients: diclofenac and dexamethasone. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Diclofenac is a nonsteroidal anti-inflammatory drug used to treat pain; dexamethasone is a corticosteroid. These are prescription medications and should not be present in dietary supplements or herbal products without proper labeling, dosing guidance, and safety information.

Consumers with this product should not use it. If you have concerns about your health after using this product, consult your healthcare provider.

The recalled product

Product
Arti King Refozado con Ortiga y Omega 3 Tablets, 100-count bottles, Hecho en Mexico por: "PLANTAS MEDICINALES DE MEXICO", Melchor Ocampo No. 55 Local D, Delegacion Xochimilco, C.P. 16800 Mexico, UPC 7 501031 111138
Manufacturer
Latin Foods Market

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 (3)

  • Lot 334 21
  • Exp: 30 Nov
  • 2025

Distribution

Distributed nationwide across the United States.

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