On 23rd january 2026, DRAP issued a Rapid Alert of Spurious Tablet EFASTON®
DRAP Alert No: No I/S/01-26-136
Action Date: 23 January 2026
Issued By
Drug Regulatory Authority of Pakistan (DRAP) on the basis of findings from Drug Testing Laboratory, Government of the Punjab.
Target Audience
National Regulatory Field Force
Healthcare Professionals (Gynecologists, Obstetricians, Pharmacists, Drug Distributors, Hospitals, Clinics)
General Public
Reason for Recall
Samples of the below-mentioned drug product were declared Spurious by the Drug Testing Laboratory, Government of the Punjab.
Product Information
Product name: Efaston® Tablets
Active ingredient: Dydrogesterone 10 mg
Batch number: 51062
Drug Registration No.: 064835
Manufacturer: Lahore Chemical & Pharmaceutical Works (Pvt.) Ltd., Lahore
Drug Manufacturing Licence (DML) No.: 000064
Laboratory Findings / Remarks
Declared Spurious under Section 3(zb)(i) of the Drugs Act, 1976
Declared active ingredient Dydrogesterone was not detected
Assay result showed 0.0 mg per tablet against the labeled claim of 10 mg
Risk Statement
Use of Efaston® (Dydrogesterone 10 mg), Batch No. 51062, poses a serious risk to patient safety
Absence of the active ingredient may result in complete therapeutic failure
May lead to unmanaged gynecological and hormonal conditions
Potential risk of pregnancy-related complications and adverse maternal outcomes
Immediate recall and discontinuation are necessary to prevent patient harm
Pictures of Spurious batch of EFASTON® tablet Issued by DRAP
Actions Taken
The Regulatory Field Force has been instructed to conduct surveillance and seize the above-mentioned spurious medicine.
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.
Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms@dra.gov.pk.
Guidance for Healthcare Professionals
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.
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Guidance for Consumers
Consumers must avoid this product. 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. (2026, January 23). Rapid alert – Spurious tablet EFASTON – Batch # 51062 [Recall alert]. https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/136-rapid-alert-spurious-tablet-efaston-batch-51062/
Disclaimer
This content is shared solely for educational and public awareness purposes and is based on publicly available DRAP safety alerts and recall notices. It does not represent an official DRAP communication, medical advice, or regulatory directive. Readers consult qualified healthcare professionals before making any medical or regulatory decisions.tus nec ullamcorper mattis, pulvinar dapibus leo.
