FDA recalls Artri King tablets for undeclared diclofenac
Botanical Be is recalling 235 bottles of Artri King tablets sold nationwide. The tablets contain undeclared diclofenac and were marketed without FDA drug approval.
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 recall. The product was marketed without required drug approval while containing an undeclared pharmaceutical ingredient, diclofenac.
Plain-English summary
This is an FDA Class I recall of Artri King Reforzado con Origa y Omega 3 tablets. Botanical Be is recalling 235 bottles of the product distributed nationwide. The tablets contain undeclared diclofenac, a nonsteroidal anti-inflammatory drug, and were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Diclofenac is a prescription and over-the-counter medication that can cause serious adverse effects and interactions with other drugs. When present in an unapproved product without proper disclosure, it poses a significant health risk to consumers who may be unaware they are taking a pharmaceutical agent.
Affected product: Artri King Reforzado con Origa y Omega 3, 100-count bottles, Lot 35421, expiration date 12/19/2025, UPC 7501031111138, manufactured by Plantas medicinales de Mexico.
If you have purchased this product, do not use it. Consult a healthcare provider if you have already taken these tablets.
The recalled product
- Product
- Artri King Reforzado con Origa y Omega 3 tablets, packaged in 100-count bottles, Manufactured by: Plantas medicinales de Mexico, Melchol Ocampo # 65 Local D, Delegacion Xochimilco CP 16800, Mexico DF, UPC 7 501031 111138
- Manufacturer
- Botanical Be
- Category
- Drug
- Affected units
- 235
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 35421
- exp 12/19/2025
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Botanical Be under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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