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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Dietary Supplements

D.B.P. Distribution: Titanium 4000 Capsules Recalled for Undeclared Sildenafil and Tadalafil

Agency Publication Date: May 22, 2019
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Summary

D.B.P. Distribution is recalling Titanium 4000 (4000 mg) capsules because they contain undeclared sildenafil and tadalafil, which are the active ingredients in FDA-approved prescription drugs for erectile dysfunction. These undeclared drug ingredients can interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. The recalled product was sold nationwide in single-count blister cards within 30-count display boxes and is marked with an expiration date of 12/29/2020. Consumers should contact their healthcare provider or pharmacist for guidance regarding this product.

Risk

The product contains hidden drug ingredients, sildenafil and tadalafil, which can pose a significant health risk to consumers with underlying medical conditions, such as diabetes, high blood pressure, or heart disease. Specifically, these ingredients can interact with nitrates used in common heart medications, causing a life-threatening drop in blood pressure.

What You Should Do

  1. Check your medicine cabinet for Titanium 4000 capsules (4000 mg) in 1-count blister cards with UPC 86077000020.
  2. Verify if your product has the expiration date 12/29/2020 printed on the packaging.
  3. Stop using this product immediately and contact your healthcare provider or pharmacist if you have experienced any health problems while taking it.
  4. Return any unused product to the place of purchase for a refund and contact D.B.P. Distribution for further instructions.
  5. For additional information or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Contact healthcare provider and return product for refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Titanium 4000, capsule, 4000 mg
UPC Codes:
86077000020
Date Ranges: Expiration 12/29/2020

Product Images

“Front of Package, Titanium 4000 capsules”

“Front of Package, Titanium 4000 capsules”

“Back of package, Titanium 4000 capsules”

“Back of package, Titanium 4000 capsules”

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82758
Status: Resolved
Manufacturer: D.B.P. Distribution
Sold By: Titanium 4000
Manufactured In: United States
Units Affected: unknown
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.