The Recall Desk
ModerateFDA (Food)·F-0538-2016·Announced 2016-02-24

Sunset Natural Products Recalls Chardon de Marie Dietary Supplement

Sunset Natural Products is recalling Chardon de Marie dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

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 driven by a consent decree and regulatory compliance issues rather than reported illnesses or specific product defects, fitting the criteria for a voluntary precautionary or compliance-based recall.

Plain-English summary

Sunset Natural Products Inc. is recalling Chardon de Marie, a dietary supplement sold in 60-capsule bottles. The recall involves 3,260 bottles (200,000 capsules) distributed in Florida and Nevada. The specific lot number is 141214, with an expiration date of 12/17 and UPC 897666001157.

This recall is being conducted pursuant to a consent decree that prohibits the company and its owners from marketing dietary supplements until they recall and destroy the products manufactured or distributed since April 2, 2014. The decree also requires the company to hire a cGMP expert and receive written permission from the FDA to resume operations.

Consumers who have purchased 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
Chardon de Marie, 60 capsules per bottle. Manufactured by Sunset Natural Products

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 # 141214 Exp. Date 12/17 UPC 897666001157

Distribution

Distributed in 2 states:

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.

See all 10 products in this recall →