The Recall Desk
SevereFDA (Food)·F-0994-2017·Announced 2017-01-04

Sunset Natural Products Recalls DHEA 25 mg Bulk Capsules

Sunset Natural Products Inc. is recalling DHEA 25 mg bulk capsules pursuant to a consent decree requiring the destruction of supplements manufactured 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 over a three-year period, indicating significant regulatory concerns about manufacturing practices.

Plain-English summary

Sunset Natural Products Inc. is recalling DHEA 25 mg, bulk capsules. The recall involves 1,444,900 capsules distributed to Florida, Nevada, and the Dominican Republic. Specific lot numbers and expiration dates are listed in the recall documentation, including lots expiring between August 2017 and August 2018.

This recall is being conducted pursuant to a consent decree entered on September 25, 2015. The decree prohibits the company and its owners from marketing dietary supplements until they recall and destroy 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 company is also required to hire a cGMP expert and receive written permission from the FDA to resume operations.

Consumers who have purchased 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
DHEA 25 mg, bulk capsules
Manufacturer
Sunset Natural Products Inc.
Category
Food — Dietary Supplement
Hazard
Affected units
1,444,900

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 (17)

  • 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 # 140714 Exp. Date 08/17
  • Lot # 310914 Exp. Date 10/17
  • Lot # 560914 Exp. Date 10/17
  • Lot # 271214 Exp. Date 12/17
  • Lot # 070115 Exp. Date 01/18
  • Lot # 460315 Exp. Date 04/18
  • Lot # 080615 Exp. Date 08/18

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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