Unregistered Indian-Origin Illegal & Unsafe Sildenafil Tablets (PENAGRA, VEGA, COBRA) Being Sold Illegally
Recall Alert | September 12, 2025
DRAP Alert No: I/S/09-25-62
Date of Action: 12th September 2025
Target Audience
DRAP Regulatory Field Force & Provincial Drug Control Departments
Healthcare Professionals
Pharmacies & Medical Stores
Issue Identified
The Drug Regulatory Authority of Pakistan (DRAP) has detected illegal and unsafe brands of sildenafil tablets circulating in the local market under the names:
PENAGRA 100 mg
VEGA 100 mg
COBRA 125 mg
Findings (Unregistered Drug Products)
1. PENAGRA TABLETS 100 mg
Generic: Sildenafil 100 mg/tablet
Batch No.: BPTE-24134
Manufacturer (as per label): M/s BANSON PHARMACEUTICALS PVT. LTD.
Status: Substandard (failed assay for sildenafil content) & Unregistered (Falsified)
2. VEGA 100 TABLETS
Generic: Sildenafil 100 mg/tablet
Batch No.: NIL (Untraceable)
Manufacturer (as per label): M/s HAB PHARMACEUTICAL & RESEARCH INDIA
Status: Unregistered (Falsified)
3. COBRA 125 MG TABLETS
Generic: Sildenafil 125 mg/tablet
Batch No.: BCB-98
Manufacturer (as per label): M/s Combitic Global Caplet Pvt. Ltd., India
Status: Unregistered (Falsified)
These products were being sold illegally by a paddler who is currently absconding.
Risk Statement
Use of these products poses a serious risk to public health.
PENAGRA (substandard) may result in ineffective treatment, unpredictable dosing, or harmful side effects.
PENAGRA, VEGA, and COBRA are all unregistered and falsified, meaning they bypass DRAP’s stringent quality, safety, and efficacy standards.
Such products may contain unknown or dangerous ingredients and carry a high risk of treatment failure and adverse health outcomes.
Medicines from black markets, paddlers, online sellers, or social media vendors are especially unsafe and should never be used.
Actions Taken
The Regulatory Field Force has been instructed to conduct surveillance and seize the above-mentioned unregistered/falsified products.
Pharmacists, chemists, distributors, and healthcare professionals must urgently inspect their stocks. Details of suppliers of such products should be reported to the Regulatory Field Force (DRAP and Provincial Drug Control Departments) to ensure removal from circulation.
Guidance for Healthcare Professionals
DRAP advises healthcare professionals to remain vigilant in pharmacies, healthcare facilities, and supply chains potentially affected by these products. Any adverse events or quality concerns linked to these medicines should be reported to the National or Provincial Pharmacovigilance Centres via the Adverse Event Reporting Form or through the official online portal.
Guidance for Consumers
Consumers must avoid these products. If anyone experiences health problems after using them, they should immediately consult a healthcare provider and report the incident to DRAP / the National Pharmacovigilance Centre.
Always purchase therapeutic goods only from licensed pharmacies or authorized outlets. Carefully check the authenticity and condition of products, and consult a pharmacist or healthcare professional in case of doubt.
Reference:
Drug Regulatory Authority of Pakistan. (2025, September 12). Rapid Alert – Unregistered / Illegal & Unsafe Sildenafil Tablets (PENAGRA, VEGA, COBRA) Being Sold Illegally [Recall Alert]. https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/rapid-alert-unregistered-illegal-unsafe-sildenafil-tablets-penagra-vega-cobra-being-sold-illegally/
