The Recall Desk
SevereFDA (Food)·F-0954-2017·Announced 2017-01-04

Sunset Natural Products Recalls Weight Control Capsules Under Consent Decree

Sunset Natural Products Inc. is recalling Weight Control 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, and the recall is mandated by a consent decree requiring the destruction of all products manufactured over a three-year period, indicating significant regulatory concerns about the firm's compliance with cGMPs.

Plain-English summary

Sunset Natural Products Inc. is recalling Weight Control, 60 capsules per bottle, pursuant to a consent decree with the U.S. Food and Drug Administration. The decree prohibits the company and its owners from marketing dietary supplements until they recall and destroy 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 recall involves 2,000 bottles (35,000 capsules) of the product. Known lot information includes Lot # 250115 with an expiration date of 01/18. The 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 for disposal or return, as the recall is being conducted under FDA supervision to ensure destruction of the affected inventory.

The recalled product

Product
Weight Control, 60 capsules per bottle

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 # 250115 Exp. Date 01/18

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 →