The Recall Desk
ModerateFDA (Food)·F-1689-2015·Announced 2015-04-08

Health One Recalls Grape Skin Extract Complex Due to cGMP Violations

Health One Pharmaceuticals is recalling Grape Skin Extract Complex capsules due to significant violations of dietary supplement manufacturing 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 significant cGMP violations, which aligns with the rubric for moderate severity involving regulatory non-compliance without reported specific acute health hazards like pathogens or allergens.

Plain-English summary

Health One Pharmaceuticals Inc is voluntarily recalling 6,538 units of Grape Skin Extract Complex, 60 capsules. 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 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 product code is 9389.

Consumers who have purchased this product should stop using it and return it to the place of purchase for a refund or contact Health One Pharmaceuticals for further instructions.

The recalled product

Product
Grape Skin Extract Complex, 60 capsules
Manufacturer
Health One Pharmaceuticals Inc
Category
Food — Dietary Supplement
Hazard
Affected units
6,538

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)

  • 9389

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 →

Related recalls

Same manufacturer · Health One Pharmaceuticals Inc

See all →

Same hazard · cGMP violation

See all →