Sunset Natural Products Recalls Hepasil Dietary Supplement Capsules
Sunset Natural Products Inc. is recalling Hepasil dietary supplements under a consent decree requiring the destruction of products distributed since April 2, 2014.
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 is driven by a consent decree regarding manufacturing compliance rather than reported illnesses or specific acute hazards, fitting the criteria for a moderate severity voluntary or regulatory recall.
Plain-English summary
Sunset Natural Products Inc. is recalling Hepasil, a dietary supplement sold in bulk quantities of 500,000 capsules. The recall is being conducted pursuant to a consent decree that prohibits the company and its owners from marketing dietary supplements until specific corrective actions are completed.
The consent decree requires the company to recall and destroy dietary supplements that have been manufactured or distributed since April 2, 2014. Additionally, the company must hire a cGMP expert and receive written permission from the FDA to resume operations. The affected product is identified by Lot # 080315 with an expiration date of 03/18.
The product was distributed in Florida and Nevada. Consumers who possess this product should stop using it and follow the instructions provided by the recalling firm or the FDA regarding disposal or return.
The recalled product
- Product
- Hepasil, sold in bulk of 500,000 capsules.
- Manufacturer
- Sunset Natural Products Inc.
- Category
- Food — Dietary Supplement
- Affected units
- 500,000
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)
- Lot # 080315 Exp. Date 03/18
Distribution
Part of a larger recall action
This product is one of 10 recalled by Sunset Natural Products 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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