Overview of the Recall On September 10, 2025, the Drug Regulatory Authority of Pakistan (DRAP) issued an urgent recall alert for Famila 28F Tablets, a widely used contraceptive and iron supplement. The recall affects four specific batches—K159, K196, K197, and K198—manufactured by ZAFA Pharmaceutical Laboratories (Pvt.) Ltd., located in SITE North Karachi.

Why Were These Batches Recalled? The Central Drugs Laboratory Karachi declared these batches substandard after identifying serious quality control failures. The issues include:

  • Content uniformity failures for Levonorgestrel and Ethinyl Estradiol
  • Weight variation in Ferrous Iron tablets
  • Assay failures indicating incorrect dosage levels of hormonal ingredients

These defects compromise the product’s effectiveness and safety, especially for women relying on it for contraception and iron supplementation.

Health Risks Associated with Substandard Batches The compromised quality of Famila 28F Tablets may lead to:

  • Reduced contraceptive efficacy, increasing the risk of unintended pregnancy
  • Hormonal imbalance, potentially causing irregular cycles or mood changes
  • Inconsistent iron supplementation, which may worsen anemia or fatigue
  • Complications for vulnerable groups, including young women, perimenopausal women, and patients with comorbidities

DRAP emphasizes that these risks are significant and warrant immediate action from both healthcare providers and consumers.

Action Steps for Distributors and Pharmacies DRAP has directed its Regulatory Field Force and Provincial Drug Control Departments to:

  • Conduct market surveys to detect and remove affected batches
  • Quarantine and return remaining stocks to the supplier
  • Report any suspected batches using DRAP’s online form or official email

Pharmacists and chemists are urged to inspect their inventories and halt distribution of the listed batches immediately.

Guidance for Healthcare Professionals Medical professionals should:

  • Increase vigilance across supply chains
  • Report adverse reactions or quality issues to the National Pharmacovigilance Centre (NPC)
  • Advise patients on alternative contraceptive options if they’ve used the affected product

Advice for Consumers Consumers should:

  • Stop using Famila 28F Tablets from the affected batches
  • Consult their physician if they’ve experienced any side effects or health concerns
  • Purchase medicines only from licensed pharmacies and verify batch numbers before use
  • Report suspicious products to DRAP or their local health authority

Conclusion This recall serves as a critical reminder of the importance of pharmaceutical quality control and consumer awareness. DRAP’s swift action aims to protect public health and ensure that only safe, effective medicines remain in circulation. Stay informed, check your medications, and always consult healthcare professionals when in doubt.