The Recall Desk
SevereFDA (Food)·F-0991-2017·Announced 2017-01-04

Sunset Natural Products Recalls Foni Bulk Capsules Under Consent Decree

Sunset Natural Products Inc. is recalling Foni bulk capsules pursuant to a consent decree requiring the destruction of dietary 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 score of 4 (Severe) per the rubric, as it involves a significant risk of temporary or medically reversible adverse health consequences.

Plain-English summary

Sunset Natural Products Inc. is recalling Foni bulk capsules. This action is being taken pursuant to a consent decree that prohibits the company and its owners from marketing dietary supplements until specific conditions are met. The decree requires the firm to 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 covers 120,000 capsules. Products were distributed to Florida, Nevada, and the Dominican Republic. Known lots include Lot # 370614 with an expiration date of 06/17 and Lot # 170215 with an expiration date of 03/18. The recall is conducted under FDA supervision in accordance with the procedures provided in the consent decree.

Consumers who have purchased these products should stop using them and follow the instructions provided by the recalling firm or the FDA regarding the destruction or return of the product. The consent decree also requires the firm to hire a cGMP expert and receive written permission from the FDA to resume operations.

The recalled product

Product
Foni, bulk capsules
Manufacturer
Sunset Natural Products Inc.
Category
Food — Dietary Supplement
Hazard
Affected units
120,000

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 (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 # 370614 Exp. Date 06/17
  • Lot # 170215 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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