The Recall Desk
ModerateFDA (Food)·F-1672-2015·Announced 2015-04-08

Health One Recalls Gentiana Combination Supplements for cGMP Violations

Health One Pharmaceuticals is recalling Gentiana Combination 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 moderate severity.

Plain-English summary

Health One Pharmaceuticals Inc. is recalling Gentiana Combination, 100 Vegetarian Capsules, 500mg. The recall involves 401 units of the product. The company identified significant violations of the current Good Manufacturing Practice (cGMP) regulations for dietary supplements as the reason for the recall.

The affected product was distributed nationwide in the United States, specifically in California, Tennessee, Washington, and Idaho. It was also distributed internationally in Hong Kong, Vietnam, China, and Singapore. The recall includes products with codes 7896 and 9198.

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
Gentiana Combination, 100 Vegetarian Capsules, 500mg
Manufacturer
Health One Pharmaceuticals Inc
Category
Food — Dietary Supplement
Hazard
Affected units
401

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 (2)

  • 7896
  • 9198

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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