The Recall Desk
SevereFDA (Food)·F-1074-2017·Announced 2017-01-04

Sunset Natural Products Recalls Collagen Hydrolyzed Dietary Supplements

Sunset Natural Products Inc. is recalling Collagen Hydrolyzed 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, which aligns with the 'Severe' criteria for significant regulatory action and potential risk.

Plain-English summary

Sunset Natural Products Inc. is recalling Collagen Hydrolyzed Dietary Supplements of unknown container size. The recall is being conducted pursuant to a consent decree that prohibits the company and its owners from marketing dietary supplements until specific corrective actions are completed.

The consent decree requires the firm to recall and destroy, under FDA supervision, all dietary supplements 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 decree also requires the firm to hire a cGMP expert and receive written permission from the FDA to resume operations.

Products were distributed to Florida, Nevada, and the Dominican Republic. Known lots include # 070614, 130714, 010814, 331014, 241214, 250215, 050415, 190715, and 160815. Consumers should stop using the product and follow the instructions provided by the recalling firm or the FDA.

The recalled product

Product
Collagen Hydrolyced Dietary Supplement (unknown container size)

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 (19)

  • 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 # 070614
  • 130714
  • 010814
  • 331014
  • 241214
  • 250215
  • 050415
  • 190715
  • 160815

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 →