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CriticalFDAfda-D-1080-2020UNDECLARED ALLERGEN

Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement Manufactured For: Natural Remedies San Antonio, TX, USA 1(87...

⚠ Critical Alert — Stop Using Immediately

This product has been flagged with severe risks (undeclared allergen). Stop using it now and contact the brand or FDA for a refund, repair, or replacement.

Category
Units Affected
19,156
Recall Date
March 16, 2020
Issuing Agency
Hazard
Undeclared Allergen

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-D-1080-2020.

Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-D-1080-2020.

Recall terminated by FDA.

✅ What you should do

  1. Stop using the product if you own it.
  2. Check the model number, lot code, or sell-by date against the recall notice above.
  3. Contact Y-o Management Llc, Dba Natural Remedy Store or the retailer where you bought it for a refund, replacement, or repair.
  4. For the most current official instructions, visit the FDA recall page.
  5. If you've been hurt by this product, report the incident to FDA.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-D-1080-2020.

Y-O Management LLC, dba Natural Remedy Store

FDA

About the U.S. Food and Drug Administration

The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.

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📣 Report a food, supplement, or cosmetic problem to the FDA

If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.

How to report to FDAFile a report at FDA

Y-o Management Llc, Dba Natural Remedy Store Recall FAQ

Y-o Management Llc, Dba Natural Remedy Store is the subject of a supplements safety report: Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement Manufactured For: Natural Remedies San Antonio, TX, USA 1(87.... The notice was published on March 16, 2020 by the U.S. Food and Drug Administration (FDA). Approximately 19,156 units are potentially affected.