Health One Pharmaceuticals Recalls Saw Palmetto Plus Dietary Supplements
Health One Pharmaceuticals is recalling Saw Palmetto Plus, 60 capsules, due to significant violations of cGMP regulations for dietary supplements.
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 allergens or pathogens, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Health One Pharmaceuticals Inc is recalling Saw Palmetto Plus, 60 capsules, due to significant violations of the current Good Manufacturing Practice (cGMP) regulations for dietary supplements. The recall involves 456 units of the product.
The affected product is identified by code 9203. Distribution was nationwide in the US, specifically in California, Tennessee, Washington, and Idaho, as well as internationally in Hong Kong, Vietnam, China, and Singapore.
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
- Saw Palmetto Plus, 60 capsules
- Manufacturer
- Health One Pharmaceuticals Inc
- Category
- Food — Dietary Supplement
- Hazard
- Affected units
- 456
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)
- 9203
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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