The Recall Desk
SevereFDA (Food)·F-1076-2017·Announced 2017-01-04

Sunset Natural Products Recalls First Defense Probiotic Dietary Supplement

Sunset Natural Products Inc. is recalling First Defense Probiotic Dietary Supplement pursuant to a consent decree requiring the destruction of products 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, which aligns with the 'Severe' criteria for significant regulatory action and potential risk.

Plain-English summary

Sunset Natural Products Inc. is recalling First Defense Probiotic Dietary Supplement of unknown container size. The recall is being conducted pursuant to a consent decree entered on September 25, 2015, which 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.

The recall covers products distributed to Florida, Nevada, and the Dominican Republic. Known lot numbers include 240414, 050215, 480315, 490315, and 370815. 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 this product should stop using it and follow the instructions provided by the recalling firm or the FDA regarding the return or destruction of the product.

The recalled product

Product
First Defense Probiotic 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 (15)

  • 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 # 240414
  • 050215
  • 480315
  • 490315
  • 370815

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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