CLASS I Drug recall · Reported 6 Jun 2018 · FDA Enforcement Report
7K capsules recalled by Shoreside Enterprises
Shoreside Enterprises is recalling 7K capsules, distributed nationwide in the US. The recall was initiated on 17 May 2018 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-0880-2018
- FDA event ID
- 80128
- Recalling firm
- Shoreside Enterprises, Tampa, FL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 17 May 2018
- FDA classified
- 18 Jun 2018
- Reported
- 6 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
Timeline
| 17 May 2018 | Recall initiated by company | |
| 6 Jun 2018 | Published in enforcement report | +20 days |
| 18 Jun 2018 | Classified by FDA | +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: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Product as listed by the FDA
7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. San Diego, CA 92108, UPC 601577513148
Where it was distributed
Nationwide.
Questions about this recall
Is 7K capsules recalled?
Yes. Shoreside Enterprises recalled 7K capsules on 17 May 2018. The recall is Class I and its status is Terminated. Recall number D-0880-2018.
Why was it recalled?
Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Which lots are affected?
Lot #: RO, Exp. 12/31/2021
Where was it sold?
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 Shoreside Enterprises
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Poseidon Xtreme Platinum 4500,1000mg recalled by Shoreside Enterprises | Shoreside Enterprises | Labeling Errors | Nationwide |