Maharashtra FDA Declares Wellness Capsules Spurious After Detecting Undisclosed Erectile Dysfunction Drug
· Free Press Journal
Mumbai, November 7, 2026: A capsule marketed as Urja Urbpro has been declared spurious after laboratory tests detected tadalafil, a prescription drug commonly used to treat erectile dysfunction, in the product without it being declared as an ingredient.
The Maharashtra FDA laboratory found 8.67 mg of tadalafil in each capsule, raising concerns over consumers unknowingly ingesting a pharmaceutical drug while believing they are taking a wellness product.
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The finding is part of the Central Drugs Standard Control Organisation's (CDSCO) September 2026 drug quality alert, which identified 330 samples as not of standard quality (NSQ) or spurious across the country. Maharashtra accounted for 18 samples in the list.
Undeclared Drug Raises Health Concerns
Tadalafil works by improving blood flow and is prescribed for erectile dysfunction and certain other medical conditions. However, its undisclosed presence in a product can expose consumers to unexpected drug interactions and side effects, particularly when they are unaware of what they are consuming.
The drug can cause headaches, dizziness, flushing, indigestion, nasal congestion and back pain. More seriously, when taken with nitrate-based medicines commonly prescribed for angina and certain heart conditions, tadalafil can cause a potentially dangerous fall in blood pressure. People with certain cardiovascular conditions may also require medical assessment before taking it.
Laboratory Tests Confirm Tadalafil Content
The Maharashtra FDA's laboratory detected the substance through TLC and HPLC identification tests and found 8.67 mg per capsule. The sample, Batch No. URJA702, was manufactured in May 2026 by Urbofort, Sri Ganganagar, Rajasthan, and had an expiry date of April 2029. It was declared spurious under Section 33-EEA(d) of the Drugs and Cosmetics Act, 1940.
Mercury Found In Imported Beauty Creams
The Maharashtra list also contains other concerning findings. Two samples of Goree beauty creams manufactured in Pakistan were found to contain mercury at levels far above the permissible limit of one part per million. One sample recorded 89,733.04 ppm of mercury, while another recorded 47,477.53 ppm. Laboratory tests also detected hydroquinone and, in one of the samples, mometasone furoate.
Several Medicines Fail Quality Tests
Other flagged products include Osarsmart 40 Trio, a blood pressure medicine that contained only 51.80 per cent of its stated cilnidipine content; Acelio-Plus, a pain-relief combination with only 32.33 per cent of its stated serratiopeptidase content; and Famotidine 40 mg tablets, which contained 78.98 per cent of the labelled drug content and failed additional quality tests.
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Maharashtra FDA Crackdown: 43 Food Licences Suspended, 17,824 Kg Of Products Worth ₹63.09 Lakh Seized Ahead Of DiwaliThe list further includes antibiotics, asthma medication, aspirin, vitamin C tablets and antiseptic solutions that failed different quality parameters.
The findings relate to the specific batches tested and do not establish that all batches of these products are defective. Consumers should consult their doctors or pharmacists if they have concerns about a medicine they are taking, rather than stopping prescribed treatment on their own.
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