The Recall Desk
SevereFDA (Food)·F-0986-2017·Announced 2017-01-04

Sunset Natural Products Recalls Gludo Bulk Capsules Under Consent Decree

Sunset Natural Products Inc. is recalling 1,530,000 units of Gludo bulk capsules pursuant to a consent decree requiring the destruction of supplements manufactured since April 2014.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the mandatory nature of the recall under a consent decree.

Plain-English summary

Sunset Natural Products Inc. is recalling 1,530,000 units of Gludo, bulk capsules. This action is being taken pursuant to a consent decree that prohibits the company and its owners from marketing dietary supplements until they recall and destroy the products, hire a cGMP expert, and receive written permission from the FDA to resume operations.

The recall covers all dietary supplements manufactured, prepared, processed, packed, labeled, held, and/or distributed between April 2, 2014, and the date of the decree's entry on September 25, 2015. The products were distributed to Florida, Nevada, and the Dominican Republic. Specific lot numbers and expiration dates are listed in the official recall documentation.

Consumers who have purchased these products should stop using them and follow the instructions provided by the recalling firm or the FDA for disposal or return.

The recalled product

Product
Gludo, bulk capsules
Manufacturer
Sunset Natural Products Inc.
Category
Food — Dietary Supplements
Hazard
Affected units
1,530,000

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 (17)

  • 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
  • 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

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 163 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 163 products in this recall →

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