The Recall Desk
ModerateFDA (Food)·F-1726-2015·Announced 2015-04-08

Health One Pharmaceuticals Recalls Kidney Tonic for cGMP Violations

Health One Pharmaceuticals is recalling 1,438 units of Kidney Tonic due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II due to cGMP violations. Per the rubric, this falls under 'Moderate' as it involves a voluntary precautionary recall without reported illnesses or specific high-risk pathogens named in the source text.

Plain-English summary

Health One Pharmaceuticals Inc is voluntarily recalling 1,438 units of Kidney Tonic dietary supplements. The recall was initiated because the product was found to have significant violations of the current Good Manufacturing Practice (cGMP) regulations for dietary supplements.

The affected products were distributed nationwide in the United States, specifically in California, Tennessee, Washington, and Idaho. Additionally, the products were distributed internationally in Hong Kong, Vietnam, China, and Singapore. The product code associated with the recall is 9666.

Consumers who have purchased this product should stop using it and contact Health One Pharmaceuticals Inc for further instructions or a refund. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Kidney Tonic
Affected units
1,438

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 (1)

  • 9666

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 147 recalled by Health One Pharmaceuticals Inc under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 147 products in this recall →