Osilex-D Tablet (Glitz Pharma) – Voluntary Recall Alert

Q: Which batch of osilex-D tablet is recalled?

Osilex-D tablet (Batch no. T22125) has been voluntarily recalled by Glitz pharma. The company started the recall after noting changes in the physical appearance of the above batch during stability testing. These changes were found to be outside the approved quality specifications.

Q: Why Glitz Pharma recalled osilex-D tablet batch?

Osilex-D tablet (Batch no. T22125) has been voluntarily recalled by Glitz pharma. The company started the recall after noting changes in the physical appearance of the above batch during stability testing. These changes were found to be outside the approved quality specifications.

Voluntary Recall of Drug Product – Osilex-D (Glitz Pharma)

DRAP Alert No.: II/V/03-26-14
Action Date: 11 March 2026

Target Audience:

National Regulatory Field Force
Healthcare professionals, including physicians, pharmacists, and nurses working in hospitals and clinics
General public

Issue / Problem:

M/s Glitz Pharma, located at 205, Muhammadi Plaza, College Road, Rawalpindi, Pakistan, with its manufacturing facility at Plot No. 265, Industrial Triangle, Kahuta Road, Islamabad, has notified the Drug Regulatory Authority of Pakistan (DRAP) of a voluntary recall of a specific batch of its drug product. This action was taken after a quality defect was identified during ongoing stability studies.

Therapeutic Goods Affected:

Product Name: Osilex-D Tablet (combination of ossein mineral complex and vitamin-D)
Batch Number: T22125
Manufacturer: M/s Glitz Pharma
Manufacturing Site: Plot No. 265, Industrial Triangle, Kahuta Road, Islamabad
DML No.: 000571
Manufacturing Date: August 2025
Expiry Date: July 2027

Reason for Recall:

The company started the recall after noting changes in the physical appearance of the above batch during stability testing. These changes were found to be outside the approved quality specifications.

Risk Statement:

The recalled batch of Osilex-D Tablet showed changes in physical appearance during stability studies. While no adverse events have been reported so far, failure to meet approved quality standards could affect the product’s quality, safety, and effectiveness. The recall is therefore being carried out as a precautionary step to protect public health and maintain regulatory compliance.

Actions Taken

The Regulatory Field Force has been instructed to conduct surveillance and seize the above-mentioned batch of the medication.

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.

How to download VigiMobile App for ADRs reporting

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, March 11). 17. Volunatry recall. Osilex-D (Glitz Pharma). https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/17-volunatry-recall-osilex-d-glitz-pharma/