The Recall Desk
SevereFDA (Drugs)·D-0654-2021·Announced 2021-07-21

Poseidon Platinum 3500 Capsules Recalled for Undeclared Prescription Drugs

Poseidon Platinum 3500 capsules are being recalled because they contain undeclared sildenafil and tadalafil, which are prescription drugs that were not approved for this product. The safety and efficacy of these undeclared ingredients have not been established.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class I, which indicates a serious health hazard. Undeclared prescription drugs with unapproved formulations present significant risk due to unknown safety and efficacy profiles.

Plain-English summary

Yamtun7, the manufacturer, is recalling Poseidon Platinum 3500 capsules (1-count per blister card, UPC 0 95842 05876 0) distributed by Poseidon and made in the USA. The product was found to contain undeclared sildenafil and tadalafil, which are prescription drugs.

The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Because sildenafil and tadalafil are unapproved drugs in this formulation, their safety and efficacy have not been established. All lots distributed between July 1, 2019 and September 28, 2020 are affected by this recall.

Consumers who have purchased this product should not use it. The exact distribution scope is unknown because the firm's eBay account was closed. Consult a healthcare provider with questions about this product.

The recalled product

Product
Poseidon Platinum 3500 capsule, 1-count per blister card, Distributed by: Poseidon, Made in the USA, UPC 0 95842 05876 0
Manufacturer
Yamtun7
Category
Drug — Unapproved Drug
Hazard
  • undeclared-prescription-drug
  • unapproved-drug
  • sildenafil
  • tadalafil

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots distributed 07/01/2019 through 09/28/2020.

Distribution

Distribution scope not specified by the agency.

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