The Recall Desk
SevereFDA (Food)·F-0915-2017·Announced 2017-01-04

Sunset Natural Products Recalls Oxy Extreme Dietary Supplement

Sunset Natural Products Inc. is recalling Oxy Extreme 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 about cGMP compliance.

Plain-English summary

Sunset Natural Products Inc. is recalling Oxy Extreme, a dietary supplement sold in bottles of 90 capsules. The recall involves 1,200 bottles, totaling 108,000 capsules. The products were distributed to Florida, Nevada, and the Dominican Republic. The known lot number is 181014 with an expiration date of 10/17.

This recall is being conducted 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. The company is also required to hire a cGMP expert and receive written permission from the FDA to resume operations.

Consumers who have purchased Oxy Extreme should stop using the product and contact the recalling firm for further instructions. The recall is supervised by the FDA in accordance with the procedures outlined in the consent decree.

The recalled product

Product
Oxy Extreme, 90 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 (11)

  • 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 and expiration date: Lot # 181014 Exp. Date 10/17

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 →

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