The Recall Desk
SevereFDA (Food)·F-0990-2017·Announced 2017-01-04

Sunset Natural Products Recalls Horsil Bulk Capsules Under Consent Decree

Sunset Natural Products Inc. is recalling Horsil bulk capsules pursuant to a consent decree requiring the destruction of dietary 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, which corresponds to a severity score of 4 (Severe) per the rubric, as it involves a significant risk of temporary or medically reversible adverse health consequences.

Plain-English summary

Sunset Natural Products Inc. is recalling Horsil bulk capsules. The recall is being conducted pursuant to a consent decree that prohibits the company and its owners from marketing dietary supplements until specific conditions are met.

The consent decree requires the firm to recall and destroy all dietary supplements that were manufactured, prepared, processed, packed, labeled, held, and/or distributed between April 2, 2014, and the date the decree was entered on September 25, 2015. The decree also requires the company to hire a cGMP expert and receive written permission from the FDA to resume operations.

Known lots include Lot # 360614 with an expiration date of 07/17 and Lot # 251014 with an expiration date of 11/17. The products were distributed to Florida, Nevada, and the Dominican Republic. Consumers should stop using the product and follow the instructions provided by the recalling firm or the FDA.

The recalled product

Product
Horsil, bulk capsules
Manufacturer
Sunset Natural Products Inc.
Category
Food — Dietary Supplement
Hazard
Affected units
330,000

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 (12)

  • 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 # 360614 Exp. Date 07/17
  • Lot # 251014 Exp. Date 11/17

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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