Sunset Natural Products Recalls Argindione Dietary Supplement Capsules
Sunset Natural Products Inc. is recalling Argindione capsules pursuant to a consent decree requiring the destruction of supplements manufactured or 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 (cGMP) rather than a specific reported health hazard or contamination event, fitting the criteria for a moderate severity voluntary or compliance-driven recall.
Plain-English summary
Sunset Natural Products Inc. is recalling Argindione, a dietary supplement sold in bulk quantities of 50,000 capsules. The recall covers Lot # 480514 (Expiration Date 05/17) and Lot # 320614 (Expiration Date 06/17). The total quantity involved is 100,000 capsules.
The recall is being conducted pursuant to a consent decree that prohibits the company and its owners from marketing dietary supplements until specific conditions are met. These conditions include the recall and destruction of dietary supplements manufactured or distributed since April 2, 2014, the hiring of a cGMP expert, and receiving written permission from the FDA to resume operations.
The affected products were distributed in Florida (FL) and Nevada (NV). Consumers who possess these specific lots of Argindione should stop using them and follow the instructions provided by the recalling firm or the FDA regarding the destruction of the product.
The recalled product
- Product
- Argindione, sold as bulk of 50,000 capsules.
- Manufacturer
- Sunset Natural Products 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)
- Lot # 480514 Exp. Date 05/17 and Lot # 320614 Exp. Date 06/17
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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