Maharashtra FDA Declares Wellness Capsules Spurious After Detecting Undisclosed Erectile Dysfunction Drug

Mumbai, November 7, 2026 - A wellness capsule labeled Urja Urbpro has been deemed spurious by the Maharashtra FDA after laboratory tests revealed the presence of tadalafil, an erectile dysfunction medication, without it being listed as an ingredient. The FDA laboratory discovered 8.67 mg of tadalafil in each capsule, a level that raises concerns about consumers unknowingly consuming a pharmaceutical drug while believing they are ingesting a wellness product.

This finding aligns with a September 2026 drug quality alert by the Central Drugs Standard Control Organisation (CDSCO), which identified 330 samples as not meeting standard quality or being spurious across India, with Maharashtra accounting for 18 samples. Tadalafil, known for improving blood flow, is prescribed for erectile dysfunction and other medical conditions.

However, its undisclosed presence poses health risks, as it can trigger adverse reactions like headaches, dizziness, and, when combined with nitrate-based medicines for heart conditions, could lead to dangerously low blood pressure. The FDA's laboratory confirmed the tadalafil content via TLC and HPLC identification tests, with the sample Batch No. URJA702 manufactured in May 2026 by Urbofort, Sri Ganganagar, Rajasthan, and having an expiry date of April 2029, declared spurious under Section 33-EEA(d) of the Drugs and Cosmetics Act, 1940.

The Maharashtra FDA's list also includes issues with imported beauty creams containing excessive mercury, medicines failing content quality, and other products failing various quality parameters. Consumers are advised to consult healthcare professionals regarding any concerns about medications, rather than discontinuing prescribed treatments without medical guidance.