The Recall Desk
ModerateFDA (Food)·F-1665-2015·Announced 2015-04-08

Health One Pharmaceuticals Recalls Hoketsu Dietary Supplements for cGMP Violations

Health One Pharmaceuticals is recalling 329 units of Hoketsu dietary supplements 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, which typically indicates a risk of temporary or medically reversible adverse health consequences. No specific illnesses, injuries, or high-risk pathogens are reported in the source text, placing it in the Moderate category.

Plain-English summary

Health One Pharmaceuticals is voluntarily recalling 329 units of a dietary supplement product named Hoketsu. 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 units were distributed nationwide in the United States, specifically in California, Tennessee, Washington, and Idaho. The product was also distributed internationally in Hong Kong, Vietnam, China, and Singapore. The specific code information associated with the recalled units is 9654.

Consumers who have purchased this product should stop using it and contact Health One Pharmaceuticals for further instructions or a refund. The U.S. Food and Drug Administration (FDA) has classified 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
Hoketsu
Manufacturer
Health One Pharmaceuticals Inc
Category
Food — Dietary Supplements
Hazard
Affected units
329

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)

  • 9654

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 →

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