The Drug Regulatory Authority of Pakistan (DRAP) has issued a nationwide recall alert for five batches of auto-disable syringes manufactured by three different companies after laboratory testing found them to be substandard and potentially unsafe for medical use.
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According to DRAP Alert No. I/S/06-26-34 issued on June 8, 2026, the affected syringe batches failed the Self-Destructive Performance or Auto-Disability Test, a critical safety feature designed to prevent syringes from being reused after a single injection.
The alert was issued following recommendations from the Drug Testing Laboratory (DTL) Sindh in Karachi, which examined samples of the medical devices and determined that they did not meet required quality standards.
Which Syringe Batches Have Been Recalled?
DRAP identified five affected batches belonging to three manufacturers located in different parts of Pakistan.
The recalled products include:
The regulator declared all these batches substandard due to failure of the auto-disable mechanism.
Why Is the Recall Important?
Auto-disable syringes are specifically designed to become permanently unusable after a single injection. This safety mechanism helps prevent the reuse of syringes, a major public health concern in many developing countries.
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According to DRAP, failure of the self-destructive feature may allow healthcare workers or unauthorized individuals to reuse the syringes, increasing the risk of transmitting serious blood-borne diseases.
The authority warned that defective syringes could contribute to the spread of diseases such as Hepatitis B, Hepatitis C and HIV. Reuse of contaminated syringes can also result in cross-contamination, healthcare-associated infections and other serious health complications.
Following the laboratory findings, DRAP has directed its field force and provincial drug control departments to immediately conduct market surveys and remove the affected batches from circulation.
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Manufacturers, distributors and suppliers have been instructed to initiate an immediate recall of the affected products in accordance with regulatory requirements.
The authority has also advised pharmacists, medical stores and healthcare facilities to inspect their inventories, stop supplying the recalled batches and quarantine remaining stock until it can be returned to suppliers.
Advice for Healthcare Professionals and Consumers
DRAP has urged hospitals, clinics, pharmacies and healthcare professionals to remain vigilant and verify that none of the affected syringe batches are being used.
Any adverse reactions, quality defects or safety concerns associated with the products should be reported to the National Pharmacovigilance Centre (NPC) under DRAP.
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Consumers and healthcare facilities currently in possession of the affected syringes have been advised to stop using them immediately and contact suppliers, distributors or manufacturers for replacement or return.
Pakistan continues to face challenges related to blood-borne infections, particularly Hepatitis B and Hepatitis C, which are often linked to unsafe injection practices.
To address these concerns, health authorities have promoted the use of auto-disable syringes in hospitals, clinics and immunization programmes.
DRAP routinely monitors the quality of medical devices and medicines through laboratory testing and issues recalls whenever products are found to pose a risk to public health.
