Health One Pharmaceuticals Recalls Man Formula Dietary Supplement
Health One Pharmaceuticals is recalling Man Formula dietary supplements due to significant violations of 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 and involves cGMP violations without reported illnesses or specific acute hazards like pathogens or allergens, fitting the Moderate category for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Health One Pharmaceuticals Inc is recalling Man Formula, 80 capsules, 500mg, due to significant violations of the current Good Manufacturing Practice (cGMP) regulations for dietary supplements.
The recall involves 1,179 units of the product. The affected product was distributed 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 is 9185.
Consumers who have purchased this product should stop using it and contact Health One Pharmaceuticals Inc for further instructions or a refund.
The recalled product
- Product
- Man Formula, 80 capsules, 500mg
- Manufacturer
- Health One Pharmaceuticals Inc
- Category
- Food — Dietary Supplement
- Hazard
- Affected units
- 1,179
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)
- 9185
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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