Sunset Natural Products Recalls Muira Puama Dietary Supplement
Sunset Natural Products Inc. is recalling Muira Puama dietary supplements 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 prohibiting the company from marketing supplements until specific corrective actions are taken, which aligns with the 'Severe' criteria for significant regulatory intervention.
Plain-English summary
Sunset Natural Products Inc. is recalling Muira Puama, 50 mg, Dietary Supplement. 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 products were distributed to Florida, Nevada, and the Dominican Republic. The source text identifies Lot # 101214 as a known lot. 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 destruction of the product.
The recalled product
- Product
- Muira Puama, 50 mg, Dietary Supplement
- Manufacturer
- Sunset Natural Products Inc.
- Category
- Food — Dietary Supplement
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 # 101214
Distribution
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 →Related recalls
Same manufacturer · Sunset Natural Products Inc.
See all →- SevereSunset Natural Products Recalls Equs Dietary Supplement Under Consent Decree
FDA (Food) · 2017-01-04
- SevereSunset Natural Products Recalls Prostate Plus Dietary Supplement
FDA (Food) · 2017-01-04
- SevereSunset Natural Products Recalls Kelp Acerola and Green Tea Capsules
FDA (Food) · 2017-01-04
- SevereSunset Natural Products Recalls Jagra Dietary Supplement Under Consent Decree
FDA (Food) · 2017-01-04
- SevereSunset Natural Products Recalls Collagen Hydrolyzed Dietary Supplements
FDA (Food) · 2017-01-04
Same hazard · regulatory violation
See all →- ModerateOne Step P in vitro diagnostic test lacks FDA premarket clearance
FDA (Devices) · 2026-05-13
- ModerateOne Step K in vitro diagnostic test recall for missing FDA clearance
FDA (Devices) · 2026-05-13
- ModerateOne Step pH In Vitro Diagnostic Test Recalled Without FDA Clearance
FDA (Devices) · 2026-05-13
- HighCucumber mint lemonade distributed unpasteurized in violation of juice HACCP rules
FDA (Food) · 2025-08-20
- HighGreen Reviver juice distributed unpasteurized in violation of juice HACCP rules
FDA (Food) · 2025-08-20