Agency classClass IIOur severity:Moderate FDA (Food)·F-1926-2013·Announced 2013-10-02

Healthmaxx Recalls Hyper II DHA/EPA Softgels Due to Mislabeling

Healthmaxx Global Inc. is voluntarily recalling Hyper II DHA/EPA softgels because the label does not match the actual product or ingredients.

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 mislabeling of ingredients and product identity, which fits the rubric for minor labeling errors or low-risk contamination without reported illness.

Plain-English summary

Healthmaxx Global Inc. is voluntarily recalling 2,863 bottles of Hyper II DHA/EPA, 100 Count Softgels. The recall was initiated in response to a U.S. Food and Drug Administration (FDA) inspection.

The FDA identified mislabeling issues where the product named on the label is not the actual product contained, and the ingredients listed are not the actual ingredients contained. The affected product is identified by Lot # F0202 and UPC 6 65176 05274 3.

The recalled product was distributed in California, Maryland, and New York. Consumers should stop using the product and return it to the place of purchase for a refund.

The recalled product

Product: Hyper II DHA/EPA, 100 Count Softgels. Product labeling reads in part:"Hyper II DHA/EPA Refined Deep Sea Fish Oil 50% DHA - 30% EPA***Dietary Supplement 100 Softgels***6 65176 05274 3***Manufactured for:HealthMax Products Co. Altadena, CA 91001***".
Manufacturer: Healthmaxx Global Inc.
Category: Food — Dietary Supplement
Hazard: mis-labeling
Affected units: 2,863

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)

Lot # F0202 UPC 6 65176 05274 3

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 28 recalled by Healthmaxx Global 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 28 products in this recall →

Same manufacturer · Healthmaxx Global Inc.

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