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Sunset Natural Products Inc.

FDA recall F-0958-2017 · Class II · reported 2017-01-04 · Terminated

Product
Chardon De Marie, 60 capsules per bottle
Reason
Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
Quantity
23,665 Bottles, (1,420,000 capsules)
Distribution
Products distributed to Florida, Nevada and the Dominican Republic
Firm location
FL, United States
Initiated
FDA Mandated
First notice
Letter
Recall started
2015-10-13
Terminated
2017-04-10
Code info
As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with the procedures provided in paragraph 6, ALL dietary supplements that were manufactured, prepared, processed, packed, labeled, held and/or distributed between April 2, 2014 and the date of entry of this Decree." The Decree was entered on September 25, 2015. Known lots and expiration dates: Lot # 290414 Exp. Date 04/17, Lot # 280414 Exp. Date 05/17, Lot # 660514 Exp. Date 06/17, Lot # 030714 Exp. Date 07/17, Lot # 670514 Exp. Date 07/17, Lot # 680514 Exp. Date 10/17, Lot # 131214 Exp. Date 12/17, Lot # 151214 Exp. Date 02/18

Source: U.S. Food and Drug Administration, openFDA Food Enforcement database (openFDA Food Enforcement, imported 2026-09). The FDA does not validate openFDA data for completeness or accuracy. This is a record of an enforcement action, not safety advice.

Sunset Natural Products Inc.: Chardon De Marie, 60 capsules per bottle | FoodFactsUSA