The Recall Desk
SevereFDA (Food)·F-0974-2017·Announced 2017-01-04

Sunset Natural Products Recalls Horny Goat Weed Capsules Under Consent Decree

Sunset Natural Products Inc. is recalling 1,100,000 units of Horny Goat Weed bulk capsules pursuant to a consent decree requiring the destruction of supplements 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 manufactured over a three-year period, indicating significant regulatory concerns about the firm's compliance and product safety.

Plain-English summary

Sunset Natural Products Inc. is recalling 1,100,000 units of Horny Goat Weed bulk capsules. This action is taken pursuant to a consent decree entered on September 25, 2015, which 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.

The affected products were distributed to Florida, Nevada, and the Dominican Republic. Specific lot numbers and expiration dates associated with the recall include Lot # 320414 (Exp. 05/17), Lot # 590614 (Exp. 07/17), Lot # 510814 (Exp. 09/17), Lot # 210914 (Exp. 09/17), Lot # 540914 (Exp. 10/17), Lot # 570914 (Exp. 10/17), Lot # 151014 (Exp. 11/17), Lot # 350215 (Exp. 03/18), Lot # 350415 (Exp. 05/18), and Lot # 020115 (Exp. 01/18).

Consumers who possess these products should stop using them and follow the instructions provided by the recalling firm or the FDA to ensure the products are destroyed under FDA supervision as required by the decree.

The recalled product

Product
Horny Goat Weed, bulk capsules
Manufacturer
Sunset Natural Products Inc.
Category
Food — Dietary Supplement
Hazard
Affected units
1,100,000

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 (20)

  • 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 # 320414 Exp. Date 05/17
  • Lot # 590614 Exp. Date 07/17
  • Lot # 510814 Exp. Date 09/17
  • Lot # 210914 Exp. Date 09/17
  • Lot # 540914 Exp. Date 10/17
  • Lot # 570914 Exp. Date 10/17
  • Lot # 151014 Exp. Date 11/17
  • Lot # 350215 Exp. Date 03/18
  • Lot # 350415 Exp. Date 05/18
  • Lot # 020115 Exp. Date 01/18

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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