The Recall Desk
SevereFDA (Food)·F-0913-2017·Announced 2017-01-04

Sunset Natural Products Recalls Project #3 Dietary Supplement Capsules

Sunset Natural Products Inc. is recalling Project #3 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, which corresponds to a score of 4 (Severe) per the rubric, as it involves a significant health risk or temporary/reversible adverse health consequences.

Plain-English summary

Sunset Natural Products Inc. is recalling Project #3, a dietary supplement sold in 60-capsule bottles. The recall is being conducted pursuant to a consent decree entered on September 25, 2015, which 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.

The recall covers 1,940 bottles, totaling 120,000 capsules. The products were distributed to Florida, Nevada, and the Dominican Republic. Known lots include Lot # 021014 with an expiration date of 10/17 and Lot # 041114 with an expiration date of 11/17.

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, as the products are subject to destruction under FDA supervision.

The recalled product

Product
Project #3, 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 (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 # 021014 Exp. Date 10/17
  • Lot # 041114 Exp. Date 11/17

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 →