The Recall Desk
ModerateFDA (Food)·F-1704-2015·Announced 2015-04-08

Health One Pharmaceuticals Recalls Breathe Free Dietary Supplements

Health One Pharmaceuticals is recalling Breathe Free dietary supplements due to significant violations of 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 Breathe Free, 90 Veggie Capsules, a dietary supplement. The recall was initiated due to significant violations of the current Good Manufacturing Practice (cGMP) regulations for dietary supplements.

The affected product consists of 1,331 units with code 8940. Distribution was 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 this product should stop using it and contact the manufacturer for further instructions or a refund.

The recalled product

Product
Breathe Free, 90 Veggie Capsules
Affected units
1,331

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)

  • 8940

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 →