The Recall Desk
ModerateFDA (Food)·F-1761-2015·Announced 2015-04-08

Health One Pharmaceuticals Recalls Stomaisu Dietary Supplements for cGMP Violations

Health One Pharmaceuticals is recalling Stomaisu dietary supplements due to significant violations of current Good Manufacturing Practice (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 text cites cGMP violations without reporting specific illnesses or injuries, aligning with a Moderate severity rating for a voluntary precautionary recall based on regulatory compliance.

Plain-English summary

Health One Pharmaceuticals is voluntarily recalling Stomaisu, 90 capsules, a dietary supplement product. The recall is being conducted because the product was found to have significant violations of the current Good Manufacturing Practice (cGMP) regulations for dietary supplements.

The affected product consists of 1,145 units of Stomaisu, 90 capsules. The distribution pattern includes nationwide sales in the United States, specifically in California, Tennessee, Washington, and Idaho, as well as international distribution to Hong Kong, Vietnam, China, and Singapore. The specific code information associated with the recall is 9749.

Consumers who have purchased this product should stop using it and contact Health One Pharmaceuticals for further instructions or a refund. The recall is driven by manufacturing compliance issues rather than a specific reported contamination or illness.

The recalled product

Product
Stomaisu, 90 capsules
Manufacturer
Health One Pharmaceuticals Inc
Category
Food — Dietary Supplement
Hazard
Affected units
1,145

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)

  • 9749

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

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.

See all 147 products in this recall →

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