The Recall Desk
ModerateFDA (Food)·F-1739-2015·Announced 2015-04-08

Health One Pharmaceuticals Recalls Newzealand Colostrum Tablets for cGMP Violations

Health One Pharmaceuticals is recalling Newzealand Colostrum Tablets due to significant violations of current Good Manufacturing Practice (cGMP) regulations for dietary supplements.

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 due to cGMP violations. Per the rubric, this falls under 'Moderate' as it involves a voluntary precautionary recall without reported illnesses or specific high-risk pathogens, and the agency classification does not mandate a higher score.

Plain-English summary

Health One Pharmaceuticals is voluntarily recalling Newzealand Colostrum Tablets. 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 consists of 100,000 units of Newzealand Colostrum Tablets. The distribution pattern indicates the product was 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 this recall is 1933.

Consumers who have purchased these tablets should stop using them and contact Health One Pharmaceuticals for further instructions or a refund. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
Newzealand Colostrum Tablets
Manufacturer
Health One Pharmaceuticals Inc
Category
Food — Dietary Supplement
Hazard
Affected units
100,000

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)

  • 1933

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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