The Recall Desk
SevereFDA (Food)·F-1018-2017·Announced 2017-01-04

Sunset Natural Products Recalls Power Max Dietary Supplement Under Consent Decree

Sunset Natural Products Inc. is recalling Power Max Dietary Supplement pursuant to a consent decree requiring the destruction of products manufactured or distributed since April 2, 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 severity score (4) 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 Power Max Dietary Supplement pursuant to a consent decree entered on September 25, 2015. 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. The firm must also hire a cGMP expert and receive written permission from the FDA to resume operations.

The affected products were distributed to Florida, Nevada, and the Dominican Republic. Known lot numbers include 540814 and 100815. The recall covers all dietary supplements manufactured or distributed during the specified period, not just the specific lots listed.

Consumers who have purchased Power Max Dietary Supplement should stop using the product and follow the instructions provided in the consent decree or contact the recalling firm for further information. The FDA is supervising the recall and destruction of the products.

The recalled product

Product
Power Max 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 (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 lot: Lot # 540814
  • 100815

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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