The Recall Desk
ModerateFDA (Food)·F-1751-2015·Announced 2015-04-08

Health One Pharmaceuticals Recalls Pyrola Dietary Supplements for cGMP Violations

Health One Pharmaceuticals is recalling Pyrola 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, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible health consequences. The source cites cGMP violations without reporting specific illnesses or injuries, aligning with a moderate severity assessment for manufacturing compliance issues.

Plain-English summary

Health One Pharmaceuticals is voluntarily recalling Pyrola dietary supplements. The recall is being conducted because the product was found to have significant violations of the current good manufacturing practice (cGMP) regulations for dietary supplements.

The recall involves 372,000 units of the product. The distribution pattern indicates the supplements were sold nationwide in the United States, specifically in California, Tennessee, Washington, and Idaho, as well as internationally in Hong Kong, Vietnam, China, and Singapore. The product code associated with the recall is 9656.

Consumers who have purchased Pyrola dietary supplements should stop using the product and contact Health One Pharmaceuticals for further instructions or a refund. The recall is driven by manufacturing compliance issues rather than a specific reported contamination or illness.

The recalled product

Product
Pyrola
Manufacturer
Health One Pharmaceuticals Inc
Category
Food — Dietary Supplements
Hazard
Affected units
372,000

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)

  • 9656

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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