The Recall Desk
ModerateFDA (Food)·F-1056-2017·Announced 2017-01-04

Sunset Natural Products Recalls Denta Capsule Dietary Supplement

Sunset Natural Products Inc. is recalling Denta capsule dietary supplements pursuant to a consent decree requiring the destruction of products manufactured or distributed 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 classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The source text does not report specific illnesses, injuries, or deaths, nor does it identify a specific high-risk pathogen or allergen, placing it in the moderate range for a voluntary/consent decree-driven recall without reported harm.

Plain-English summary

Sunset Natural Products Inc. is recalling Denta capsule dietary supplements of unknown container size. 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 specific conditions are met.

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. A known lot number for this recall is # 120415.

The affected products were distributed to Florida, Nevada, and the Dominican Republic. Consumers who possess these products should stop using them and follow the instructions provided by the recalling firm or the FDA regarding disposal or return.

The recalled product

Product
Denta capsule 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 (11)

  • 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 # 120415

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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