Table of contents
- Latest Active Male by Natural Remedy Lawsuit Updates
- March 16, 2020: Natural Remedy Store Recalls Active Male
- What Is Active Male by Natural Remedy?
- Who May Be Affected?
- Reported Injuries or Damages
- Recall and Regulatory Background
- Evidence to Preserve
- Filing Deadlines
- Frequently Asked Questions
- What Should I Do with Leftover Active Male Capsules?
- Where Can I Report a Problem with Active Male?
- Which Medicines Should I Tell My Doctor About Before Tadalafil?
- Why Is Undeclared Tadalafil a Problem in a Supplement?
Active Male 500 mg capsules, sold by Natural Remedy Store in San Antonio, Texas, were recalled because FDA analysis found undeclared tadalafil. The drug can be dangerous for people who take nitrates because it may drop blood pressure too far.
No lawsuit, MDL or class action has been filed over Active Male. FDA has terminated the recall that Natural Remedy Store announced on March 16, 2020.
If you still have the capsules, stop using them and talk to a doctor about any health problems you think they may have caused.
Latest Active Male by Natural Remedy Lawsuit Updates
March 16, 2020: Natural Remedy Store Recalls Active Male
Natural Remedy Store announced a voluntary recall of all lots of Active Male 500 mg capsules to the consumer level. The cause was undeclared tadalafil. FDA posted the announcement the same day [1].
Consumers were told to stop using the capsules and return them to the place of purchase or call (210) 798-5433.
What Is Active Male by Natural Remedy?
FDA says Active Male is sold as a dietary supplement for male enhancement. It is marketed to boost sexual performance. FDA analysis found it tainted with tadalafil.
MedlinePlus, from the National Library of Medicine, says tadalafil is used to treat erectile dysfunction. It is also sold as Cialis [2].
Who May Be Affected?
People who bought Active Male at the San Antonio shop of Natural Remedy Store or through NaturalRemedyStore.com and took it may be affected. Anyone who also takes prescription nitrates such as nitroglycerin faces the main risk FDA names.
FDA says people with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates. They may be the group most likely to be affected.
Whether you have a claim depends on your own facts, and only an individual legal review can say whether your situation qualifies.
Reported Injuries or Damages
No injury has been reported to the company. Natural Remedy Store told FDA it had received no adverse events related to the recall. That is a company statement, and it does not show that no one was harmed.
FDA warns that tadalafil with nitrates may lower blood pressure to dangerous levels. This can be life threatening. It is FDA’s warning about risk and not a report of injury.
You can report adverse reactions or quality problems to FDA online, by mail or by fax through its adverse event reporting program [3]. Keep a copy of what you send.
Recall and Regulatory Background
The recall was conducted with the knowledge of FDA. FDA has terminated it, so it is no longer an open recall.
According to the FDA recall list, a terminated recall is one where FDA has found that all reasonable efforts were made. The efforts were to remove or correct the violative product [4].
Evidence to Preserve
Keep anything that shows what you took, where you bought it and what happened next:
- Packaging, a small foldable cardboard box with a Trojan helmet image and the name Active Male with BN: Nd6332
- Receipts and order confirmations from NaturalRemedyStore.com
- Recall letters from Natural Remedy Store
- Photographs of the product and the capsules
- Medical records and a list of your medicines, including any nitrates
- Notes on the dates you used the product and any symptoms
- Messages and other contact with the seller
Filing Deadlines
Filing deadlines come from state law, and the one that applies to you depends on where you live and when the harm happened.
Talk to a lawyer promptly, because a missed deadline can end a claim even when the facts are strong and the harm seems clear.
Frequently Asked Questions
What Should I Do with Leftover Active Male Capsules?
What should you do with leftover Active Male capsules? Call Natural Remedy Store Monday through Saturday, 10:00 AM to 6:00 PM Central time, or email natremedies@att.net to arrange a return. The company says it is arranging return or replacement.
Where Can I Report a Problem with Active Male?
Where can you report a problem with Active Male? Call 1-800-332-1088 to request a reporting form from FDA’s adverse event reporting program. You can also tell Natural Remedy Store, which says it has received no adverse events so far.
Which Medicines Should I Tell My Doctor About Before Tadalafil?
Which medicines should you tell your doctor about before tadalafil? MedlinePlus says to tell your doctor if you are taking or have recently taken riociguat (Adempas) or nitrates such as isosorbide dinitrate.
Why Is Undeclared Tadalafil a Problem in a Supplement?
Why is undeclared tadalafil a problem in a supplement? FDA says the product is an unapproved drug whose safety and efficacy have not been established. Tadalafil is an FDA-approved erectile dysfunction drug, but buyers were not told it was in the capsules.