The Recall Desk
SevereFDA (Food)·F-0955-2017·Announced 2017-01-04

Sunset Natural Nutrigen Dietary Supplement Recalled Under Consent Decree

Sunset Natural Products Inc. is recalling Nutrigen dietary supplements pursuant to a consent decree requiring the destruction of products 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 since 2014, indicating significant regulatory concerns regarding manufacturing practices.

Plain-English summary

Sunset Natural Products Inc. is recalling Nutrigen, 60 capsules per bottle, pursuant to a consent decree with the U.S. Food and Drug Administration. The recall involves 3,000 bottles, totaling 180,000 capsules. The products were distributed to Florida, Nevada, and the Dominican Republic. Known lots include Lot # 260115 with an expiration date of 03/18 and Lot # 210515 with an expiration date of 06/18.

The recall is mandated by a consent decree that 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 decree also requires the company to hire a cGMP expert and receive written permission from the FDA to resume operations.

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
Nutrigen, 60 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 (12)

  • 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 # 260115 Exp. Date 03/18
  • Lot # 210515 Exp. Date 06/18

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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