Agency classClass IIOur severity:Severe FDA (Food)·F-0999-2017·Announced 2017-01-04

Sunset Natural Products Recalls Maca Capsules Under Consent Decree

Sunset Natural Products Inc. is recalling Maca 250 mg capsules pursuant to a consent decree requiring the destruction of supplements 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 cGMP.

Plain-English summary

Sunset Natural Products Inc. is recalling Maca 250 mg, bulk capsules. 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 specific corrective actions are completed.

The consent decree requires the firm to recall and destroy, under FDA supervision, 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 firm must also hire a cGMP expert and receive written permission from the FDA to resume operations.

The affected product was distributed to Florida, Nevada, and the Dominican Republic. Known lots include Lot # 190814 (Exp. 08/17), Lot # 030115 (Exp. 02/18), and Lot # 190415 (Exp. 06/18). Consumers should stop using the product and follow the instructions provided by the recalling firm or the FDA regarding disposal.

The recalled product

Product: Maca 250 mg, bulk capsules
Manufacturer: Sunset Natural Products Inc.
Category: Food — Dietary Supplement
Hazard: cGMP-violation
regulatory-enforcement
Affected units: 270,000

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 (13)

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 # 190814 Exp. Date 08/17
Lot # 030115 Exp. Date 02/18
Lot # 190415 Exp. Date 06/18

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 →

Same manufacturer · Sunset Natural Products Inc.

See all →

Severe
Sunset Natural Products Recalls Equs Dietary Supplement Under Consent Decree
FDA (Food) · 2017-01-04
Severe
Sunset Natural Products Recalls Prostate Plus Dietary Supplement
FDA (Food) · 2017-01-04
Severe
Sunset Natural Products Recalls Kelp Acerola and Green Tea Capsules
FDA (Food) · 2017-01-04
Severe
Sunset Natural Products Recalls Jagra Dietary Supplement Under Consent Decree
FDA (Food) · 2017-01-04
Severe
Sunset Natural Products Recalls Collagen Hydrolyzed Dietary Supplements
FDA (Food) · 2017-01-04

Same hazard · cGMP violation