Health One Pharmaceuticals Recalls Korean Ginseng Supplements for cGMP Violations
Health One Pharmaceuticals is recalling 48,400 units of Korean Ginseng dietary supplements due to significant violations of 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 'voluntary precautionary recalls' or minor regulatory issues where no specific acute health hazard (like a pathogen or allergen) is explicitly reported, warranting a Moderate severity score.
Plain-English summary
Health One Pharmaceuticals is voluntarily recalling 48,400 units of Korean Ginseng 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 product is identified by code 8308. The supplements 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.
Consumers who have purchased this product should stop using it and contact Health One Pharmaceuticals for further instructions or a refund. The recall is classified as FDA Class II, indicating that use of or exposure to the product may create a temporary or medically reversible health risk.
The recalled product
- Product
- Korean Ginseng
- Manufacturer
- Health One Pharmaceuticals Inc
- Category
- Food — Dietary Supplements
- Hazard
- Affected units
- 48,400
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)
- 8308
Distribution
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.
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