Agency classClass IIOur severity:Severe FDA (Food)·F-1033-2017·Announced 2017-01-04

Sunset Natural Products Recalls Oyster Dietary Supplements Under Consent Decree

Sunset Natural Products Inc. is recalling Oyster Dietary Supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

The agency’s classification

FDA (Food): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 the firm's compliance with cGMPs.

Plain-English summary

Sunset Natural Products Inc. is recalling Oyster Dietary Supplements of unknown container size. This action is being taken pursuant to a consent decree that prohibits the company and its owners from marketing dietary supplements until specific conditions are met.

The consent 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 of the decree's entry on September 25, 2015. The firm must also hire a cGMP expert and receive written permission from the FDA to resume operations. Known lot number 440914 is included in this recall.

Products were distributed to Florida, Nevada, and the Dominican Republic. Consumers who possess these products should stop using them and follow the instructions provided by the recalling firm or the FDA regarding disposal.

The recalled product

Product: Oyster Dietary Supplement (unknown container size)
Manufacturer: Sunset Natural Products Inc.
Category: Food — Dietary Supplement
Hazard: cGMP-violation
regulatory-non-compliance

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 (11)

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 # 440914

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 →

Same manufacturer · Sunset Natural Products Inc.

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