Health One Pharmaceuticals Recalls Protein Powder for cGMP Violations
Health One Pharmaceuticals is recalling Protein Powder due to significant violations of current Good Manufacturing Practice (cGMP) regulations for dietary supplements.
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 cGMP violations without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Health One Pharmaceuticals is voluntarily recalling Protein Powder. The recall is being conducted because the product is subject to significant violations of the current Good Manufacturing Practice (cGMP) regulations for dietary supplements.
The affected product consists of 9,517 units of Protein Powder. 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 recall involves specific codes: 2869, 2039, 2158, 2202, and 2306.
Consumers who have purchased this product should check their inventory for the listed codes and stop using the product. The source text does not specify a particular consumer action such as returning the product or seeking a refund, nor does it report any illnesses or injuries associated with the recall.
The recalled product
- Product
- Protein Powder
- Manufacturer
- Health One Pharmaceuticals Inc
- Category
- Food — Dietary Supplements
- Hazard
- Affected units
- 9,517
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 (5)
- 2869
- 2039
- 2158
- 2202
- 2306
Distribution
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.
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