The Recall Desk
ModerateFDA (Food)·F-0956-2017·Announced 2017-01-04

Sunset Natural Products Recalls Weight 2.0 Dietary Supplement

Sunset Natural Products Inc. is recalling Weight 2.0 dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and is a voluntary precautionary recall mandated by a consent decree to ensure compliance with cGMP regulations, with no specific reported illnesses or injuries mentioned in the source text.

Plain-English summary

Sunset Natural Products Inc. is recalling Weight 2.0, 120 capsules per bottle, pursuant to a consent decree with the U.S. Food and Drug Administration. The recall covers 1,000 bottles (120,000 capsules) of the dietary supplement. The known lot number is 350315 with an expiration date of 03/18.

The recall is being conducted under a consent decree that prohibits the company and its owners from marketing dietary supplements until they recall and destroy all products 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 decree also requires the firm to hire a cGMP expert and receive written permission from the FDA to resume operations.

The affected products were distributed to Florida, Nevada, and the Dominican Republic. Consumers who have purchased this product should stop using it and follow the instructions provided by the recalling firm or the FDA regarding disposal or return.

The recalled product

Product
Weight 2.0, 120 capsules per bottle
Manufacturer
Sunset Natural Products Inc.
Category
Food — Dietary Supplement
Hazard

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 (11)

  • 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 lot and expiration date: Lot # 350315 Exp. Date 03/18

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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