The Recall Desk
SevereFDA (Food)·F-1044-2017·Announced 2017-01-04

Sunset Natural Products Recalls Aloe & L Glutamine Dietary Supplement

Sunset Natural Products Inc. is recalling Aloe & L Glutamine Dietary Supplement pursuant to a consent decree requiring the destruction of products 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric, particularly given the mandatory destruction of all products manufactured over a three-year period due to cGMP violations.

Plain-English summary

Sunset Natural Products Inc. is recalling Aloe & L Glutamine Dietary Supplement of unknown container size. 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 specific corrective actions are completed.

The consent decree requires the firm to recall and destroy, under FDA supervision, all dietary supplements manufactured, prepared, processed, packed, labeled, held, and/or distributed between April 2, 2014, and the date of the decree's entry. The firm must also hire a cGMP expert and receive written permission from the FDA to resume operations. Known lot numbers include 030814, 230115, and 140615.

The affected products were distributed to Florida, Nevada, and the Dominican Republic. Consumers who have purchased this product should stop using it and follow the instructions provided by the recalling firm or the FDA regarding disposal.

The recalled product

Product
Aloe & L Glutamine Dietary Supplement (unknown container size)
Manufacturer
Sunset Natural Products Inc.
Category
Food — Dietary Supplement
Hazard

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 (13)

  • 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 lot: Lot # 030814
  • 230115
  • 140615

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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