The Recall Desk
SevereFDA (Food)·F-0995-2017·Announced 2017-01-04

Sunset Natural Products Recalls Aloe Vera and Lecithin Capsules

Sunset Natural Products Inc. is recalling Aloe Vera & Lecithin 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 with cGMPs.

Plain-English summary

Sunset Natural Products Inc. is recalling approximately 1,457,000 units of Aloe Vera & Lecithin bulk capsules. The recall is being conducted 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. The recall covers specific lots with expiration dates ranging from July 2017 to August 2018, including Lot # 630714, Lot # 42914, Lot # 430914, Lot # 10114, Lot # 210215, Lot # 370515, Lot # 050815, and Lot # 281114.

Consumers who have purchased these products should stop using them and follow the instructions provided by the recalling firm or the FDA regarding disposal or return. The consent decree also requires the firm to hire a cGMP expert and receive written permission from the FDA to resume operations.

The recalled product

Product
Aloe Vera & Lecithin, bulk capsules
Manufacturer
Sunset Natural Products Inc.
Category
Food — Dietary Supplements
Hazard
Affected units
1,457,000

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 (18)

  • 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 # 630714 Exp. Date 07/17
  • Lot # 42914 Exp. Date 10/17
  • Lot # 430914 Exp. Date 10/17
  • Lot # 10114 Exp. Date 12/17
  • Lot # 210215 Exp. Date 03/18
  • Lot # 370515 Exp. Date 06/18
  • Lot # 050815 Exp. Date 08/18
  • Lot # 281114 Exp. Date 12/17

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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