The Recall Desk
ModerateFDA (Food)·F-0934-2017·Announced 2017-01-04

Sunset Natural Products Recalls Hepasil Dietary Supplement Capsules

Sunset Natural Products Inc. is recalling 2,650,000 capsules of Hepasil pursuant to a consent decree requiring the destruction of supplements 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 indicates a temporary or medically reversible health risk. The source text does not report any specific illnesses, injuries, or deaths, and the recall is driven by a consent decree rather than a specific contamination event, fitting the criteria for a moderate severity score.

Plain-English summary

Sunset Natural Products Inc. is recalling 2,650,000 capsules of Hepasil, a dietary supplement. The recall is being conducted pursuant to a consent decree that prohibits the company and its owners from marketing dietary supplements until they recall and destroy all supplements 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 affected products were distributed to Florida, Nevada, and the Dominican Republic. The recall covers specific lots with expiration dates ranging from April 2017 to May 2018. The consent decree also requires the firm to hire a cGMP expert and receive written permission from the FDA to resume operations.

Consumers who have purchased Hepasil should stop using the product and follow the instructions provided by the recalling firm or the FDA regarding the destruction or return of the product.

The recalled product

Product
Hepasil, (various bulk amounts)
Manufacturer
Sunset Natural Products Inc.
Category
Food — Dietary Supplement
Hazard
Affected units
2,650,000

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 (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 # 400414 Exp. Date 04/17
  • Lot # 070514 Exp. Date 05/17
  • Lot # 100614 Exp. Date 06/17
  • Lot # 110614 Exp. Date 06/17
  • Lot # 120614 Exp. Date 06/17
  • Lot # 130614 Exp. Date 06/17
  • Lot # 140614 Exp. Date 06/17
  • Lot # 150614 Exp. Date 06/17
  • Lot # 130515 Exp. Date 03/18
  • Lot # 190515 Exp. Date 05/18

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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