Health One Pharmaceuticals Recalls Schizandra Dietary Supplements for cGMP Violations
Health One Pharmaceuticals is recalling Schizandra dietary 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 but does not report specific illnesses, injuries, or deaths, aligning with a Moderate severity rating for a voluntary precautionary recall involving manufacturing standards.
Plain-English summary
Health One Pharmaceuticals is voluntarily recalling 67 units of Schizandra dietary supplements. The recall was initiated 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 7980.
Consumers who possess these products should stop using them immediately. The source text does not specify a particular return address or refund process, but consumers should contact the recalling firm, Health One Pharmaceuticals, for further instructions on how to dispose of or return the product.
The recalled product
- Product
- Schizandra
- Manufacturer
- Health One Pharmaceuticals Inc
- Category
- Food — Dietary Supplement
- Hazard
- Affected units
- 67
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)
- 7980
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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