CLASS I Drug recall · Reported 24 Apr 2019 · FDA Enforcement Report
Kopi Jantan Tradisional Natural Herbs Coffee individual packages recalled
Brian P. Richardson is recalling Kopi Jantan Tradisional Natural Herbs Coffee individual packages, distributed nationwide in the US. The recall was initiated on 5 Apr 2019 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-1206-2019
- FDA event ID
- 82584
- Recalling firm
- Brian P. Richardson, Dallas, TX
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 5 Apr 2019
- FDA classified
- 22 Apr 2019
- Reported
- 24 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
Timeline
| 5 Apr 2019 | Recall initiated by company | |
| 22 Apr 2019 | Classified by FDA | +17 days |
| 24 Apr 2019 | Published in enforcement report | +2 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 be tainted with undeclared sildenafil and tadalafil, two FDA approved drugs for the treatment of male erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Product as listed by the FDA
Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Malaysia, UPC 9 557205 060083.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared sildenafil and tadalafil, two FDA approved drugs for the treatment of male erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Which lots are affected?
All Lots labeled with EXP 13 10 2020
Where was it sold?
Nationwide in the USA
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.
More recalls from Brian P. Richardson
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | CaverFlo Natural Herbal Coffee, supplied recalled by Brian P. Richardson | Brian P. Richardson | Undeclared Milk | TX |