The Recall Desk
ModerateFDA (Food)·F-1757-2015·Announced 2015-04-08

Health One Pharmaceuticals Recalls SOD Dietary Supplements for cGMP Violations

Health One Pharmaceuticals is recalling SOD 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 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 is voluntarily recalling SOD dietary supplements. The recall is being conducted because the products were found to have significant violations of the current Good Manufacturing Practice (cGMP) regulations for dietary supplements.

The recall involves 11,038 units of the product. 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 associated with the recall is 9085.

Consumers who have purchased these SOD dietary supplements should stop using them and contact Health One Pharmaceuticals for further instructions or a refund.

The recalled product

Product
SOD
Manufacturer
Health One Pharmaceuticals Inc
Category
Food — Dietary Supplements
Hazard
Affected units
11,038

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)

  • 9085

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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