Health One Pharmaceuticals Recalls BCAA Supplements for cGMP Violations
Health One Pharmaceuticals is recalling BCAA with Lemon Lime supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 could cause temporary or medically reversible health consequences. The source cites cGMP violations without reporting specific illnesses or injuries, fitting the Moderate severity criteria for voluntary precautionary or compliance-based recalls.
Plain-English summary
Health One Pharmaceuticals is voluntarily recalling 1,118 units of BCAA with Lemon Lime dietary supplements. The recall is being conducted because the products were found to have significant violations of the current Good Manufacturing Practice (cGMP) regulations for dietary supplements.
The affected products were distributed nationwide in the United States, specifically in California, Tennessee, Washington, and Idaho. Additionally, the products were distributed internationally in Hong Kong, Vietnam, China, and Singapore. The specific code information for the recalled units is 3087.
Consumers who have purchased these products should stop using them and contact Health One Pharmaceuticals for further instructions or a refund. The recall is driven by manufacturing compliance issues rather than a specific contamination or labeling error identified in the source text.
The recalled product
- Product
- BCAA with Lemon Lime
- Manufacturer
- Health One Pharmaceuticals Inc
- Category
- Food — Dietary Supplement
- Hazard
- Affected units
- 1,118
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)
- 3087
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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