Natural Remedies Active Male Formula Recalled for Undeclared Tadalafil
FDA is recalling Natural Remedies Active Male 500 mg dietary supplements because they contain undeclared Tadalafil, an FDA-approved drug for erectile dysfunction.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The rubric mandates a score of 5 for FDA Class I recalls.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Natural Remedies Active Male 500 mg Male Pleasure Formula dietary supplements. The product was manufactured by Y-O Management LLC, dba Natural Remedy Store, and marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
FDA analysis determined that the product contains undeclared Tadalafil, which is an FDA-approved drug used to treat erectile dysfunction. The recall involves an estimated 19,156 packets that were distributed in Georgia and Texas. All lots remaining within their expiration dates are affected.
Consumers who have purchased this product should stop using it and contact the manufacturer or their healthcare provider for guidance. The presence of undeclared prescription drugs in dietary supplements can pose significant health risks, particularly for individuals with certain medical conditions or those taking other medications.
The recalled product
- Product
- Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement Manufactured For: Natural Remedies San Antonio, TX, USA 1(877)543-3501
- Manufacturer
- Y-O Management LLC, dba Natural Remedy Store
- Category
- Drug — Dietary Supplement
- Hazard
- Affected units
- 19,156
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 remaining within expiry.
Distribution
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