The Recall Desk
CriticalFDA (Drugs)·D-1292-2019·Announced 2019-05-22

Titanium 4000 capsules recalled for undeclared sildenafil and tadalafil

D.B.P. Distribution is recalling Titanium 4000 capsules because they contain undeclared sildenafil and tadalafil and were marketed without an approved NDA or ANDA.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

D.B.P. Distribution is recalling Titanium 4000 capsules, 4000 mg, 1 count blister card, 30 blister display box, UPC 86077000020. The product was distributed nationwide.

The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) and contains undeclared sildenafil and tadalafil. The source text does not specify the quantity of units recalled or report any specific illnesses or injuries.

Consumers should stop using the product and contact D.B.P. Distribution for further instructions or a refund.

The recalled product

Product
Titanium 4000, capsule, 4000 mg, 1 count blister card, 30 blister display boxt, distributed by Titanium 4000 UPC 86077000020
Manufacturer
D.B.P. Distribution
Category
Drug — Supplement
Hazard

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)

  • Expiration 12/29/2020

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · undeclared ingredients

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