The Recall Desk
SevereFDA (Food)·F-1072-2017·Announced 2017-01-04

Sunset Natural Products Recalls Growlean Dietary Supplement Under Consent Decree

Sunset Natural Products Inc. is recalling Growlean Dietary Supplement 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 FDA Class II, and the recall is mandated by a consent decree requiring the destruction of all products manufactured since 2014, which aligns with the 'Severe' criteria for significant regulatory action and potential structural compliance failures.

Plain-English summary

Sunset Natural Products Inc. is recalling Growlean Dietary Supplement (unknown container size) 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, 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 is part of a legal agreement that also requires the firm to hire a cGMP expert and receive written permission from the FDA to resume operations. Known lots include Lot # 490714 and 180415. The products were distributed to Florida, Nevada, and the Dominican Republic.

Consumers who have purchased Growlean Dietary Supplement should stop using the product and contact Sunset Natural Products Inc. for further instructions or a refund, as directed by the recall notice.

The recalled product

Product
Growlean 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 # 490714
  • 180415

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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