CLASS II Food recall · Reported 24 Feb 2016 · FDA Enforcement Report
Prostaliv recalled by Sunset Natural Products
Sunset Natural Products is recalling Prostaliv per, distributed in Florida, Nevada. The recall was initiated on 5 Oct 2015 and the FDA has classified it as Class II.
Check your package
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
Recall details
- Recall number
- F-0541-2016
- FDA event ID
- 72877
- Recalling firm
- Sunset Natural Products, Miami, FL
- Brand
- Prostaliv
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Oct 2015
- FDA classified
- 17 Feb 2016
- Reported
- 24 Feb 2016
- Type
- FDA Mandated
- Customers notified by
- Other
- Reason category
- Manufacturing (CGMP) Deviations
- Product category
- Dietary Supplements
Timeline
| 5 Oct 2015 | Recall initiated by company | |
| 17 Feb 2016 | Classified by FDA | +135 days |
| 24 Feb 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufatured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
Product as listed by the FDA
Prostaliv, 60 capsules per bottle. Manufactured by Sunset Natural Products
Where it was distributed
FL and NV
Questions about this recall
Is Prostaliv per recalled?
Yes. Sunset Natural Products recalled Prostaliv per on 5 Oct 2015. The recall is Class II and its status is Terminated. Recall number F-0541-2016.
Why was it recalled?
Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufatured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
Which lots are affected?
Lot # 180215 Exp Date 02/18 UPC 897666001144,
Where was it sold?
FL and NV
What should I do if I have it?
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Sunset Natural Products
All 173| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | CLASS II | True Vital recalled by Sunset Natural ProductsTrue Vital | Sunset Natural Products | Manufacturing (CGMP) Deviations | FL, NV |
| Food | CLASS II | Lebytol recalled by Sunset Natural ProductsLebytol | Sunset Natural Products | Manufacturing (CGMP) Deviations | FL, NV |
| Food | CLASS II | Oxy Extreme recalled by Sunset Natural ProductsOxy Extreme | Sunset Natural Products | Manufacturing (CGMP) Deviations | FL, NV |
| Food | CLASS II | Kelp Acerola & Green Tea, bulk capsules recalledKelp Acerola | Sunset Natural Products | Manufacturing (CGMP) Deviations | FL, NV |
| Food | CLASS II | Collagen & VIT C recalled by Sunset Natural ProductsCollagen | Sunset Natural Products | Manufacturing (CGMP) Deviations | FL, NV |
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|---|---|---|---|---|---|
| Food | ANNOUNCED | Niwali Tejocote Capsules and Pieces recalled by Global MixNiwali | Global Mix | Foreign Material | Nationwide |
| Food | CLASS I | Addall XR Shot, liquid dietary supplement recalled by ZMB EnterprisesAddall XR | ZMB Enterprises | Hidden Drug Ingredients | CA |
| Food | CLASS II | Super Skin; Dietary Supplement;, 2 per day recalled by Mellish IslandMellish Island | Mellish Island | Other | Nationwide |
| Food | CLASS I | Modern Warrior Ready, Dietary Supplement recalledModern Warrior | Modern Warrior Life | Hidden Drug Ingredients | Nationwide |
| Food | CLASS II | Vista MAX; Dietary Supplement Serving Size recalled by Provision HealthVista MAX | Provision Health | Undeclared Allergens | CA |