The Recall Desk
ModerateFDA (Food)·F-0964-2017·Announced 2017-01-04

Sunset Natural Products Recalls Vital Cure Dietary Supplement Under Consent Decree

Sunset Natural Products Inc. is recalling Vital Cure dietary supplements 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 classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The source text does not report specific illnesses or injuries, and the recall is driven by a consent decree rather than a specific contamination event, fitting the 'Moderate' criteria for voluntary or regulatory compliance actions without reported harm.

Plain-English summary

Sunset Natural Products Inc. is recalling Vital Cure, 30 capsules per bottle, pursuant to a consent decree with the U.S. Food and Drug Administration. 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 recall covers 189,533 bottles (6,136,000 capsules) distributed to Florida, Nevada, and the Dominican Republic. Specific lot numbers and expiration dates are listed in the source documentation, ranging from Lot # 660614 to Lot # 140415.

Consumers who have purchased these products should stop using them and follow the instructions provided by the recalling firm or the FDA for disposal or return, as the products are subject to destruction under FDA supervision.

The recalled product

Product
Vital Cure, 30 capsules per bottle
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 (20)

  • 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 # 660614
  • 560714 Exp. Date 07/17
  • Lot # 090814 Exp. Date 09/17
  • Lot # 280914 Exp. Date 09/17
  • Lot # 290914 Exp. Date 10/17
  • Lot # 261014 Exp. Date 11/17
  • Lot # 211114 Exp. Date 12/17
  • Lot # 011214 Exp. Date 12/17
  • Lot # 280115 Exp. Date 01/18
  • Lot # 230215 Exp. Date 03/18

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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