Health One Pharmaceuticals Recalls Tmaxx Dietary Supplement for cGMP Violations
Health One Pharmaceuticals is recalling Tmaxx 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 and involves cGMP violations without reported illnesses or specific acute hazards like allergens or pathogens, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Health One Pharmaceuticals Inc is voluntarily recalling 1,890 units of Tmaxx, 60 capsules, a dietary supplement. 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 was distributed nationwide in the United States, specifically in California, Tennessee, Washington, and Idaho. It was also distributed internationally in Hong Kong, Vietnam, China, and Singapore. The product code is 9763.
Consumers who have purchased this product should stop using it and contact Health One Pharmaceuticals for further instructions or a refund.
The recalled product
- Product
- Tmaxx, 60 capsules
- Manufacturer
- Health One Pharmaceuticals Inc
- Category
- Food — Dietary Supplement
- Hazard
- Affected units
- 1,890
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)
- 9763
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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