CLASS I Drug recall · Reported 28 Jul 2021 · FDA Enforcement Report
Shogun-X capsules recalled by Ummzy
Ummzy is recalling Shogun-X capsules, distributed nationwide in the US. The recall was initiated on 30 Mar 2021 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-0663-2021
- FDA event ID
- 87624
- Recalling firm
- Ummzy, Palisades Park, NJ
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 30 Mar 2021
- FDA classified
- 16 Jul 2021
- Reported
- 28 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
Timeline
| 30 Mar 2021 | Recall initiated by company | |
| 16 Jul 2021 | Classified by FDA | +108 days |
| 28 Jul 2021 | Published in enforcement report | +12 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: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Product as listed by the FDA
Shogun-X capsules, 10-count boxes, Manufactured by Power Life Distributors, Made in USA, UPC 118122030185
Where it was distributed
USA Nationwide
Questions about this recall
Is Shogun-X capsules recalled?
Yes. Ummzy recalled Shogun-X capsules on 30 Mar 2021. The recall is Class I and its status is Terminated. Recall number D-0663-2021.
Why was it recalled?
Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Which lots are affected?
All lots within expiry.
Where was it sold?
USA Nationwide
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.
More recalls from Ummzy
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Thumbs up, Distributed Ummzy LLC recalled | Ummzy | Labeling Errors | Nationwide |
| Drug | CLASS I | Krazy Night capsule recalled by Ummzy | Ummzy | Labeling Errors | Nationwide |