Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported July 21, 2021
Poseidon Platinum 3500 capsule, 1-count per blister card, Distributed by: Poseidon, Made in the USA, UPC 0 95842 05876 0
Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making them unapproved drugs for which the safety and efficacy have not been es…
Yamtun7 recalled Poseidon Platinum 3500 capsule, 1-count per blister card, Distributed by: Poseidon, Made … - a critical-severity action.
Poseidon Platinum 3500 capsule, 1-count per blister card, Distributed by: Poseidon, Made … was recalled by Yamtun7 in July 21, 2021. Reason: Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making th…. Check the official notice for the remedy. Verify recall #D-0654-2021 with the FDA Drug before acting.
The recall
Yamtun7 issued this critical-severity FDA Drug recall-Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making th….
- Critical
- severity level
- Class I
- classification
- July 21, 2021
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0654-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0654-2021) was formally reported on July 21, 2021, with the manufacturer initiating the action on May 11, 2021. It is classified under Critical severity (Class I), with a current status of Terminated. Yamtun7 is listed as the recalling firm, operating out of Delray Beach, FL. Federal records list the affected scope as 36 capsules.
The documented reason for this recall is: Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recal… Distribution data in the federal record shows the product reached: Unknown; unable to determine due to firm's Ebay account being closed.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
36 capsules
Related Recalls
6
5 from same agency
Product description
Poseidon Platinum 3500 capsule, 1-count per blister card, Distributed by: Poseidon, Made in the USA, UPC 0 95842 05876 0
Reason for recall
Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-0654-2021 |
| Date reported | July 21, 2021 |
| Date initiated | May 11, 2021 |
| Recalling firm | Yamtun7 |
| Firm location | Delray Beach, FL |
| Affected scope | 36 capsules |
| Distribution | Unknown; unable to determine due to firm's Ebay account being closed. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0654-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Poseidon Platinum 3500 capsule, 1-count per blister card, Distributed by: Poseidon, Made in the USA, UPC 0 95842 05876 0. Recalled by Yamtun7. Units affected: 36 capsules.
Why was this product recalled? ▼
Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 21, 2021. Severity: Critical. Recall number: D-0654-2021.
Where was the recalled product distributed? ▼
Distribution: Unknown; unable to determine due to firm's Ebay account being closed..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0654-2021) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported July 21, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.