The Recall Desk
ModerateFDA (Food)·F-0541-2016·Announced 2016-02-24

Sunset Natural Products Recalls Prostaliv Dietary Supplement Under Consent Decree

Sunset Natural Products is recalling Prostaliv dietary supplements pursuant to a consent decree requiring the destruction of products manufactured or distributed since April 2, 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, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report specific illnesses or injuries, aligning with a moderate severity rating for a regulatory compliance recall.

Plain-English summary

Sunset Natural Products Inc. is recalling Prostaliv, a dietary supplement sold in bottles of 60 capsules. The recall involves 5,000 bottles (300,000 capsules) distributed in Florida and Nevada. The specific lot number is 180215, with an expiration date of 02/18 and UPC 897666001144.

This action is being taken pursuant to a consent decree that prohibits the company and its owners from marketing dietary supplements until they recall and destroy the products manufactured or distributed since April 2, 2014. The decree also requires the company to hire a cGMP expert and receive written permission from the FDA to resume operations.

Consumers who purchased this product should stop using it and follow the instructions provided by the recalling firm or the FDA for disposal or return.

The recalled product

Product
Prostaliv, 60 capsules per bottle. Manufactured by Sunset Natural Products

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 (1)

  • Lot # 180215 Exp Date 02/18 UPC 897666001144

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 10 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 10 products in this recall →