The Recall Desk
ModerateFDA (Food)·F-1688-2015·Announced 2015-04-08

Health One Pharmaceuticals Recalls Gamma Zyme Dietary Supplements

Health One Pharmaceuticals is recalling Gamma Zyme 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 2,007 units of Gamma Zyme, 100 capsules, a dietary supplement. 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 products were distributed nationwide in the United States, specifically in California, Tennessee, Washington, and Idaho. Additionally, the products were distributed internationally in Hong Kong, Vietnam, China, and Singapore. The specific code information for the recalled units is 8816.

Consumers who have purchased Gamma Zyme, 100 capsules, should check their inventory for the code 8816. If they possess the affected product, they should stop using it and contact Health One Pharmaceuticals for further instructions or a refund.

The recalled product

Product
Gamma Zyme, 100 capsules
Manufacturer
Health One Pharmaceuticals Inc
Category
Food — Dietary Supplement
Hazard
Affected units
2,007

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)

  • 8816

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 →