The Recall Desk
SevereFDA (Food)·F-1081-2017·Announced 2017-01-04

Sunset Natural Products Recalls Diet III Dietary Supplement Under Consent Decree

Sunset Natural Products Inc. is recalling Diet III Dietary Supplement 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 Severe rating under the rubric, particularly given the context of a consent decree requiring destruction of all products due to cGMP violations.

Plain-English summary

Sunset Natural Products Inc. is recalling Diet III Dietary Supplement (unknown container size) pursuant to a consent decree. The decree 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 company must also hire a cGMP expert and receive written permission from the FDA to resume operations.

The recall covers products distributed to Florida, Nevada, and the Dominican Republic. Known lot numbers include 221014, 111214, and 121214. The recall is being conducted under FDA supervision in accordance with the procedures provided in the consent decree.

Consumers who have purchased Diet III Dietary Supplement should check their lot numbers against the known lots listed above. If the product matches the recall criteria, consumers should stop using it and follow the instructions provided by the recalling firm or the FDA for disposal or return.

The recalled product

Product
Diet III Dietary Supplement (unknown container size)
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 (13)

  • 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: Lot # 221014
  • 111214
  • 121214

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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