Health One Pharmaceuticals Recalls SutharIndia Capsules for cGMP Violations
Health One Pharmaceuticals is recalling SutharIndia capsules due to significant violations of dietary supplement 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, which typically indicates a situation where use of the product might cause temporary or medically reversible health consequences. The source cites cGMP violations without reporting specific illnesses or injuries, fitting the Moderate severity criteria for low-risk contamination or regulatory non-compliance.
Plain-English summary
Health One Pharmaceuticals is recalling SutharIndia, Capsule, a dietary supplement. 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 recalled product consists of 400 units. 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. The product code is 9496.
Consumers who have purchased this product should stop using it and contact Health One Pharmaceuticals for further instructions or a refund.
The recalled product
- Product
- SutharIndia, Capsule
- Manufacturer
- Health One Pharmaceuticals Inc
- Category
- Food — Dietary Supplement
- Hazard
- Affected units
- 400
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)
- 9496
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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