Health One Pharmaceuticals Recalls Amino Acid Supplements for cGMP Violations
Health One Pharmaceuticals is recalling Amino Acid (Youth formula) 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 involve manufacturing errors rather than direct contamination or reported illness, fitting the 'Moderate' severity criteria for low-risk or precautionary issues.
Plain-English summary
Health One Pharmaceuticals is voluntarily recalling 1,284 units of Amino Acid (Youth formula) 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 9425. 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.
Consumers who possess this product should stop using it and contact Health One Pharmaceuticals for further instructions or a refund. The FDA classifies this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Amino Acid (Youth formula)
- Manufacturer
- Health One Pharmaceuticals Inc
- Category
- Food — Dietary Supplements
- Hazard
- Affected units
- 1,284
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)
- 9425
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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