F-0994-2017 Class II Terminated
FDA food recall F-0994-2017 was initiated by Sunset Natural Products Inc. on Oct 13, 2015 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Apr 10, 2017). Affected quantity: 1,444,900 capsules.
Recall Details
- Product Type
- Food
- Report Date
- Jan 4, 2017
- Initiation Date
- Oct 13, 2015
- Termination Date
- Apr 10, 2017
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 1,444,900 capsules
Product Description
DHEA 25 mg, bulk capsules
Reason for Recall
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.
Distribution Pattern
Products distributed to Florida, Nevada and the Dominican Republic
Code Information
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 # 140714 Exp. Date 08/17, Lot # 310914 Exp. Date 10/17, Lot # 560914 Exp. Date 10/17, Lot # 271214 Exp. Date 12/17, Lot # 070115 Exp. Date 01/18, Lot # 460315 Exp. Date 04/18, Lot # 080615 Exp. Date 08/18
Source
- Dataset
- openFDA food recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for F-0994-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 23, 2026