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Sunset Natural Products Inc.
FDA recall F-0968-2017 · Class II · reported 2017-01-04 · Terminated
- Product
- Coclss, bulk capsules
- 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
- 2,400,000 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 # 090414 Exp. Date 05/17, Lot # 100414 Exp. Date 05/17, Lot # 110414 Exp. Date 05/17, Lot # 040115 Exp. Date 01/18, Lot # 160315 Exp. Date 04/18, Lot # 190615 Exp. Date 07/18, Lot # 200615 Exp. Date 07/18
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.