The Recall Desk
ModerateFDA (Food)·F-1743-2015·Announced 2015-04-08

Health One Pharmaceuticals Recalls Omega-3 Supplements for cGMP Violations

Health One Pharmaceuticals is recalling Omega-3 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 due to cGMP violations, which typically indicates a risk of temporary or medically reversible health consequences, fitting the Moderate severity criteria for regulatory non-compliance without reported acute illness.

Plain-English summary

Health One Pharmaceuticals Inc. is recalling Omega-3 dietary supplements. The recall was initiated because the products were 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. The company also distributed these supplements internationally to Hong Kong, Vietnam, China, and Singapore. The recall involves 198,480 units with code 2302.

Consumers who have purchased these products should stop using them and contact Health One Pharmaceuticals for further instructions or a refund. The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible health consequences.

The recalled product

Product
Omega-3
Manufacturer
Health One Pharmaceuticals Inc
Category
Food — Dietary Supplements
Hazard
Affected units
198,480

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)

  • 2302

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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