The Recall Desk
ModerateFDA (Food)·F-1717-2015·Announced 2015-04-08

Health One Pharmaceuticals Recalls Fish Oil 100 Dietary Supplements

Health One Pharmaceuticals is recalling Fish Oil 100 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. Per the rubric, this falls under 'Moderate' as it involves a voluntary precautionary recall with no specific reported illnesses or injuries, and the hazard is related to manufacturing compliance rather than a specific acute pathogen or allergen.

Plain-English summary

Health One Pharmaceuticals Inc. is voluntarily recalling approximately 14,730 units of Fish Oil 100 dietary supplements. The recall was initiated because the product was found to have significant violations of the current Good Manufacturing Practice (cGMP) regulations for dietary supplements.

The affected products are identified by the following codes: 122276, 122351, 132590, 132585, and 143129. These supplements were distributed nationwide in the United States, specifically in California, Tennessee, Washington, and Idaho, as well as internationally in Hong Kong, Vietnam, China, and Singapore.

Consumers who have purchased these products should stop using them and contact Health One Pharmaceuticals for further instructions or a refund. The FDA classifies 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
Fish Oil 100
Manufacturer
Health One Pharmaceuticals Inc
Category
Food — Dietary Supplements
Hazard
Affected units
14,730

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 (5)

  • 122276
  • 122351
  • 132590
  • 132585
  • 143129

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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