The Recall Desk
ModerateFDA (Food)·F-0543-2016·Announced 2016-02-24

Sunset Natural Products Recalls Prostax Forte Dietary Supplement

Sunset Natural Products Inc. is recalling Prostax Forte 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 and is driven by a consent decree regarding manufacturing compliance rather than reported illnesses or specific contamination hazards, fitting the criteria for a moderate severity voluntary or compliance-driven recall.

Plain-English summary

Sunset Natural Products Inc. is recalling Prostax Forte, a dietary supplement sold in bulk of 50,000 capsules. The recall covers Lot # 120315 with an expiration date of 03/18. The product was distributed in Florida and Nevada.

This recall is being conducted 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 have purchased this product should stop using it and contact the recalling firm for instructions on disposal or return.

The recalled product

Product
Prostax Forte, sold in bulk of 50,000 capsules.
Affected units
50,000

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 # 120315 Exp. Date 03/18

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 →