The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Food)·F-1685-2015·Announced 2015-04-08

Health One Pharmaceuticals Recalls EyesCare Dietary Supplement Capsules

Health One Pharmaceuticals is recalling EyesCare dietary supplements due to significant violations of cGMP regulations.

The agency’s classification

FDA (Food): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 significant cGMP violations, which aligns with the rubric for moderate severity involving voluntary precautionary recalls or minor labeling/process errors without reported illness.

Plain-English summary

Health One Pharmaceuticals is voluntarily recalling EyesCare, 60 capsules, a dietary supplement product. 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 affected product consists of 3,867 units. The distribution pattern includes nationwide distribution in the United States, specifically in California, Tennessee, Washington, and Idaho, as well as international distribution to Hong Kong, Vietnam, China, and Singapore. The product code is 9259.

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
EyesCare, 60 capsules
Affected units
3,867

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)

  • 9259

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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