The Recall Desk
SevereFDA (Food)·F-0984-2017·Announced 2017-01-04

Sunset Natural Products Recalls Seral Bulk Capsules Under Consent Decree

Sunset Natural Products Inc. is recalling Seral bulk capsules pursuant to a consent decree requiring the destruction of dietary supplements manufactured or distributed 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 agency classification is FDA Class II, and the recall is mandated by a consent decree requiring the destruction of all products manufactured since 2014, which aligns with the 'Severe' criteria for significant regulatory action and potential risk.

Plain-English summary

Sunset Natural Products Inc. is recalling Seral, bulk capsules, pursuant to a consent decree entered by 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 900,000 capsules distributed to Florida, Nevada, and the Dominican Republic. Specific lots identified in the decree include Lot # 010614 (Exp. 06/17), Lot # 520914 (Exp. 10/17), Lot # 530914 (Exp. 10/17), and Lot # 181114 (Exp. 12/17). The firm is also required to hire a cGMP expert and receive written permission from the FDA to resume operations.

Consumers who possess these products should stop using them and follow the instructions provided in the consent decree to ensure the products are destroyed under FDA supervision.

The recalled product

Product
Seral, bulk capsules
Manufacturer
Sunset Natural Products Inc.
Category
Food — Dietary Supplement
Hazard
Affected units
900,000

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 (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 lots and expiration dates: Lot # 010614 Exp. Date 06/17
  • Lot # 520914 Exp. Date 10/17
  • Lot # 530914 Exp. Date 10/17
  • Lot # 181114 Exp. Date 12/17

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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