The Recall Desk
SevereFDA (Food)·F-0911-2017·Announced 2017-01-04

Sunset Natural Products Recalls SoMaks Dietary Supplement Under Consent Decree

Sunset Natural Products Inc. is recalling SoMaks dietary supplements pursuant to a consent decree requiring the destruction of products manufactured or distributed 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 Class II, and the recall is mandated by a consent decree requiring the destruction of all products due to cGMP violations, which aligns with the 'Severe' criteria for significant regulatory enforcement actions.

Plain-English summary

Sunset Natural Products Inc. is recalling SoMaks, 30 capsules per bottle, pursuant to a consent decree with the U.S. Food and Drug Administration. The decree prohibits the company and its owners from marketing dietary supplements until they recall and destroy all products manufactured or distributed since April 2, 2014, hire a cGMP expert, and receive written permission from the FDA to resume operations.

The recall covers 1,000 bottles (30,000 capsules) of SoMaks. The products were distributed to Florida, Nevada, and the Dominican Republic. The known lot number is 300415 with an expiration date of 07/18. The consent decree was entered on September 25, 2015.

Consumers who have purchased SoMaks should stop using the product and contact the recalling firm for instructions on disposal or return, as the products must be destroyed under FDA supervision.

The recalled product

Product
SoMaks, 30 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 # 300415 Exp. Date 07/18

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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