The Recall Desk
SevereFDA (Food)·F-1001-2017·Announced 2017-01-04

Sunset Natural Products Recalls Collagen 300 mg Capsules Under Consent Decree

Sunset Natural Products Inc. is recalling Collagen 300 mg 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, which aligns with the 'Severe' criteria for significant regulatory action and potential risk.

Plain-English summary

Sunset Natural Products Inc. is recalling Collagen 300 mg, bulk capsules. The recall is being conducted pursuant to a consent decree that prohibits the company and its owners from marketing dietary supplements until specific conditions are met. The decree requires the firm to recall and destroy all dietary supplements manufactured, prepared, processed, packed, labeled, held, and/or distributed between April 2, 2014, and the date the decree was entered on September 25, 2015. The firm must also hire a cGMP expert and receive written permission from the FDA to resume operations.

The affected product is distributed to Florida, Nevada, and the Dominican Republic. The total quantity involved is 390,000 capsules. Specific lots and expiration dates identified in the recall include Lot # 220814 (Exp. 01/17), Lot # 431214 (Exp. 01/18), Lot # 050415 (Exp. 05/18), and Lot # 100615 (Exp. 07/18).

Consumers who have purchased these products should stop using them and follow the instructions provided by the recalling firm or the FDA regarding the destruction of the supplements.

The recalled product

Product
Collagen 300 mg, bulk capsules
Manufacturer
Sunset Natural Products Inc.
Category
Food — Dietary Supplements
Hazard
Affected units
390,000

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 # 220814 Exp. Date 01/17
  • Lot # 431214 Exp. Date 01/18
  • Lot # 050415 Exp. Date 05/18
  • Lot # 100615 Exp. Date 07/18

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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