The Recall Desk
ModerateFDA (Food)·F-1657-2015·Announced 2015-04-08

Health One Pharmaceuticals Recalls Linzhi Dietary Supplements for cGMP Violations

Health One Pharmaceuticals is recalling Linzhi 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, which typically indicates a situation where use of the product might cause temporary or medically reversible health consequences. The source text cites cGMP violations but does not report specific illnesses, injuries, or deaths, aligning with a Moderate severity rating for a voluntary precautionary recall involving manufacturing standards.

Plain-English summary

Health One Pharmaceuticals is voluntarily recalling Linzhi dietary supplements. The recall is being conducted because the product was found to have significant violations of the current Good Manufacturing Practice (cGMP) regulations for dietary supplements.

The affected product consists of 704 units of Linzhi. The distribution pattern includes nationwide sales in the United States, specifically in California, Tennessee, Washington, and Idaho, as well as international distribution to Hong Kong, Vietnam, China, and Singapore. The product codes associated with this recall are 8901 and 8240.

Consumers who have purchased Linzhi dietary supplements from Health One Pharmaceuticals should check their inventory for the specific product codes listed above. If the product matches the description and codes provided, consumers should stop using it and contact the recalling firm for further instructions or a refund.

The recalled product

Product
Linzhi
Manufacturer
Health One Pharmaceuticals Inc
Category
Food — Dietary Supplement
Hazard
Affected units
704

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)

  • 8901
  • 8240

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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