CLASS I Drug recall · Reported 13 Dec 2017 · FDA Enforcement Report
PapaZen, Proprietary Blend 1800mg packets recalled by Gadget Island
Gadget Island is recalling PapaZen, Proprietary Blend 1800mg packets, distributed nationwide in the US. The recall was initiated on 15 Sep 2017 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-0104-2018
- FDA event ID
- 78151
- Recalling firm
- Gadget Island, Newark, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 15 Sep 2017
- FDA classified
- 4 Dec 2017
- Reported
- 13 Dec 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
Timeline
| 15 Sep 2017 | Recall initiated by company | |
| 4 Dec 2017 | Classified by FDA | +80 days |
| 13 Dec 2017 | Published in enforcement report | +9 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: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Product as listed by the FDA
PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distributed by FX Power San Diego, CA 92108, UPC 718122032587
Where it was distributed
Nationwide in the USA
Questions about this recall
Is PapaZen, Proprietary Blend 1800mg packets recalled?
Yes. Gadget Island recalled PapaZen, Proprietary Blend 1800mg packets on 15 Sep 2017. The recall is Class I and its status is Terminated. Recall number D-0104-2018.
Why was it recalled?
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Which lots are affected?
Lot# NSS050888, EXP 05-2018
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 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.
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|---|---|---|---|---|---|
| Drug | CLASS I | NUX Male Enhancement capsule blister card recalled by Gadget Island | Gadget Island | Labeling Errors | Nationwide |
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| Drug | CLASS I | Dynamite Super capsule, 58,000 MG blister card recalled by Gadget Island | Gadget Island | Labeling Errors | Nationwide |
| Drug | CLASS I | Rhino 7 Platinum, Proprietary Material: 750mg packets recalled | Gadget Island | Labeling Errors | Nationwide |
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