The Recall Desk
ModerateFDA (Food)·F-1031-2017·Announced 2017-01-04

Sunset Natural Products Recalls Heci Dietary Supplement Under Consent Decree

Sunset Natural Products Inc. is recalling Heci Dietary Supplement pursuant to a consent decree requiring the destruction of products manufactured since April 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 a voluntary precautionary action mandated by a consent decree to ensure compliance with cGMP standards, with no specific reported illnesses or injuries cited in the source text.

Plain-English summary

Sunset Natural Products Inc. is recalling Heci Dietary Supplement (unknown container size) pursuant to a consent decree. The decree 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 on September 25, 2015. The company is also required to hire a cGMP expert and receive written permission from the FDA to resume operations.

The recall covers products distributed to Florida, Nevada, and the Dominican Republic. Known lot numbers include 500814, 071214, 040415, and 330615. The source text does not specify a particular health hazard, illness, or injury associated with the product; the recall is mandated by the legal terms of the consent decree.

Consumers who have purchased Heci Dietary Supplement should stop using the product and follow the instructions provided by the recalling firm or the FDA regarding disposal or return.

The recalled product

Product
Heci 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 (14)

  • 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 # 500814
  • 071214
  • 040415
  • 330615

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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