CLASS I Drug recall · Reported 8 Apr 2020 · FDA Enforcement Report
Natural Remedies Active Male 500 mg Male Pleasure Formula recalled
Y-O Management LLC is recalling Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement, distributed in Georgia, Texas. The recall was initiated on 16 Mar 2020 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1080-2020
- FDA event ID
- 85232
- Recalling firm
- Y-O Management LLC, San Antonio, TX
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 16 Mar 2020
- FDA classified
- 4 Apr 2020
- Reported
- 8 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
Timeline
| 16 Mar 2020 | Recall initiated by company | |
| 4 Apr 2020 | Classified by FDA | +19 days |
| 8 Apr 2020 | Published in enforcement report | +4 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Product as listed by the FDA
Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement Manufactured For: Natural Remedies San Antonio, TX, USA 1(877)543-3501
Where it was distributed
Distributed in GA and TX
Questions about this recall
Why was it recalled?
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
Which lots are affected?
All lots remaining within expiry.
Where was it sold?
Distributed in GA and TX
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.