The Recall Desk
ModerateFDA (Food)·F-1718-2015·Announced 2015-04-08

Health One Pharmaceuticals Recalls Fish Oil 200 for cGMP Violations

Health One Pharmaceuticals is recalling Fish Oil 200 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 involve manufacturing errors rather than direct contamination or reported injuries, fitting the Moderate severity criteria for voluntary precautionary recalls.

Plain-English summary

Health One Pharmaceuticals Inc is voluntarily recalling 38,160 units of Fish Oil 200 dietary supplements. The recall is being conducted due to 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 worldwide in Hong Kong, Vietnam, China, and Singapore. The specific lot codes associated with this recall are 143317, 112111, 112108, 122170, 122242, and 132586.

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

The recalled product

Product
Fish Oil 200
Manufacturer
Health One Pharmaceuticals Inc
Category
Food — Dietary Supplement
Hazard
Affected units
38,160

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 (6)

  • 143317
  • 112111
  • 112108
  • 122170
  • 122242
  • 132586

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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