The Recall Desk
ModerateFDA (Food)·F-1703-2015·Announced 2015-04-08

Health One Pharmaceuticals Recalls Brainy Formula Dietary Supplements

Health One Pharmaceuticals is recalling Brainy Formula 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, which typically involves a temporary or medically reversible adverse health consequence. The source cites cGMP violations without reporting specific illnesses or injuries, fitting the Moderate severity criteria for regulatory non-compliance without confirmed harm.

Plain-English summary

Health One Pharmaceuticals is recalling Brainy Formula 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 product is identified by code 9183. The recall covers 1,179 units. 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 recalling firm for further instructions or a refund.

The recalled product

Product
Brainy Formula
Affected units
1,179

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)

  • 9183

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 →