Severity
Moderate
ModerateClass IITerminated
FDA Food recall · Reported February 24, 2016
Prostamax DUO, 60 capsules per bottle. Manufactured by Sunset Natural Products
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…
Sunset Natural Products Inc. recalled Prostamax DUO, 60 capsules per bottle. Manufactured by Sunset Natural Products - a moderate-severity action.
Prostamax DUO, 60 capsules per bottle. Manufactured by Sunset Natural Products was recalled by Sunset Natural Products Inc. in February 24, 2016. Reason: Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements unti…. Check the official notice for the remedy. Verify recall #F-0542-2016 with the FDA Food before acting.
The recall
Sunset Natural Products Inc. issued this moderate-severity FDA Food recall-Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements unti….
- Moderate
- severity level
- Class II
- classification
- February 24, 2016
- reported
Sourced from official FDA Food enforcement records. Verify recall #F-0542-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Food action (record #F-0542-2016) was formally reported on February 24, 2016, with the manufacturer initiating the action on October 5, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Sunset Natural Products Inc. is listed as the recalling firm, operating out of Miami, FL. Federal records list the affected scope as 4,000 bottles (240,000 capsules).
The documented reason for this recall is: 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 distribut… Distribution data in the federal record shows the product reached: FL and NV. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
4,000 bottles (240,000 capsules)
Related Recalls
6
0 from same agency
Product description
Prostamax DUO, 60 capsules per bottle. Manufactured by Sunset Natural Products
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | F-0542-2016 |
| Date reported | February 24, 2016 |
| Date initiated | October 5, 2015 |
| Recalling firm | Sunset Natural Products Inc. |
| Firm location | Miami, FL |
| Affected scope | 4,000 bottles (240,000 capsules) |
| Distribution | FL and NV |
Profile values are sourced directly from the official FDA Food enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (F-0542-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Food before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Food record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Prostamax DUO, 60 capsules per bottle. Manufactured by Sunset Natural Products. Recalled by Sunset Natural Products Inc.. Units affected: 4,000 bottles (240,000 capsules).
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Food on February 24, 2016. Severity: Moderate. Recall number: F-0542-2016.
Where was the recalled product distributed? ▼
Distribution: FL and NV.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (F-0542-2016) against your product. Visit the official FDA Food website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
What are the health risks of consuming a recalled food product? ▼
Recalled food products may contain contaminants, undeclared allergens, or harmful bacteria such as Salmonella, Listeria, or E. coli. Consuming these products can cause foodborne illness ranging from mild gastrointestinal symptoms to serious conditions requiring hospitalization. If you have consumed a recalled food product and experience symptoms, contact your healthcare provider and report to the FDA via MedWatch.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Food, reported February 24, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.