FDA Food recall F-0986-2017

Gludo, bulk capsules

FDA Food
Class II
terminated
Published 2017-01-04

On 2017-01-04 the FDA classified a Class II recall of Gludo, bulk capsules by Sunset Natural Products, citing 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….

Read the official FDA Food notice

Agency	FDA Food
Recall number	F-0986-2017
Classification	Class II
Status	terminated
Initiated	2015-10-13
Published	2017-01-04
Last updated	2026-09-13 11:49 UTC
Company	Sunset Natural Products
Distribution	FL, NV

Product

Gludo, 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.

Identifiers

code_info	As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with… 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 # 030614 Exp. Date 07/17, Lot # 460814 Exp. Date 09/17, Lot # 080914 Exp. Date 10/17, Lot # 090914 Exp. Date 10/17, Lot # 021114 Exp. Date 11/17, Lot # 050115 Exp. Date 02/18, Lot # 030415 Exp. Date 05/18

code_info

As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with…

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 # 030614 Exp. Date 07/17, Lot # 460814 Exp. Date 09/17, Lot # 080914 Exp. Date 10/17, Lot # 090914 Exp. Date 10/17, Lot # 021114 Exp. Date 11/17, Lot # 050115 Exp. Date 02/18, Lot # 030415 Exp. Date 05/18

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:49 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/food/enforcement.json?search=recall_number:%22F-0986-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.