The Recall Desk
SevereFDA (Food)·F-0928-2017·Announced 2017-01-04

Sunset Natural Products Recalls HGH Dietary Supplement Capsules

Sunset Natural Products Inc. is recalling HGH dietary supplement capsules 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 the destruction of all products due to cGMP violations.

Plain-English summary

Sunset Natural Products Inc. is recalling HGH dietary supplements, packaged as 100 capsules per bottle. The recall involves 350 bottles, totaling 35,000 capsules. The products were distributed to Florida, Nevada, and the Dominican Republic. Known lots include Lot # 230714 with an expiration date of 07/17 and Lot # 260215 with an expiration date of 02/18.

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 dietary supplements manufactured, prepared, processed, packed, labeled, held, and/or distributed between April 2, 2014, and the date of the decree's entry. The company is also required to hire a cGMP expert and receive written permission from the FDA to resume operations.

Consumers who have purchased these products should stop using them and follow the instructions provided by the recalling firm or the FDA for disposal or return.

The recalled product

Product
HGH, 100 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 (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 lots and expiration dates: Lot # 230714 Exp. Date 07/17
  • Lot # 260215 Exp. Date 02/18

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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