Health One Pharmaceuticals Recalls Flexyln Dietary Supplements for cGMP Violations
Health One Pharmaceuticals is recalling Flexyln 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 involves a reasonable probability of temporary or medically reversible health consequences. The source cites cGMP violations without reporting specific illnesses or injuries, aligning with the Moderate severity criteria for regulatory non-compliance.
Plain-English summary
Health One Pharmaceuticals is voluntarily recalling Flexyln 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 recall involves 199,984 units of the product. Distribution was nationwide in the United States, specifically in California, Tennessee, Washington, and Idaho, as well as internationally in Hong Kong, Vietnam, China, and Singapore. The product code associated with the recall is 9427.
Consumers who have purchased Flexyln dietary supplements should stop using the product and contact Health One Pharmaceuticals for further instructions or a refund.
The recalled product
- Product
- Flexyln
- Manufacturer
- Health One Pharmaceuticals Inc
- Category
- Food — Dietary Supplements
- Hazard
- Affected units
- 199,984
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)
- 9427
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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