The Recall Desk
ModerateFDA (Food)·F-0961-2017·Announced 2017-01-04

Sunset Natural Products Recalls Prostaliv New Dietary Supplement

Sunset Natural Products Inc. is recalling Prostaliv New dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and is a voluntary precautionary action mandated by a consent decree to ensure compliance with cGMP regulations, with no specific reported illnesses or injuries cited in the source text.

Plain-English summary

Sunset Natural Products Inc. is recalling Prostaliv New, 60 capsules per bottle, pursuant to a consent decree with the U.S. Food and Drug Administration. The recall involves 15,250 bottles, containing a total of 915,000 capsules. The affected products were distributed to Florida, Nevada, and the Dominican Republic.

The recall is mandated by a consent decree that 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 decree also requires the firm to hire a cGMP expert and receive written permission from the FDA to resume operations.

Known lots include Lot # 400514 (Exp. 06/17), Lot # 180614 (Exp. 06/17), Lot # 190614 (Exp. 08/17), and Lot # 650614 (Exp. 07/17). Consumers should stop using the product and follow the instructions provided by the recalling firm or the FDA for disposal.

The recalled product

Product
Prostaliv New, 60 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 (14)

  • 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 # 400514 Exp. Date 06/17
  • Lot # 180614 Exp. Date 06/17
  • Lot # 190614 Exp. Date 08/17
  • Lot # 650614 Exp. Date 07/17

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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