US FDA bans Ajanta Pharma's Kamagra tablets — August 2024 archive

In August 2024 the US FDA placed Ajanta Pharma's Kamagra tablets on its import alert (the agency's "Red List"), detaining all shipments without examination. The agency cited manufacturing violations and potential health risks tied to product quality. This page summarizes what happened, why it matters, and practical steps for patients, pharmacies, and importers.

The FDA inspects foreign drug makers and can stop products when facilities fail to meet current Good Manufacturing Practices (cGMP). For Kamagra, repeated inspections found deficiencies that raise the risk of contamination, wrong potency, or unsanitary production. That’s why the agency decided to block imports until Ajanta addresses the problems and proves corrective actions work.

What the FDA action means

Being on the Red List means every shipment from the affected facility can be detained at the border without being sampled or tested. Importers must provide evidence that fixes are in place and that the product is safe before the FDA will allow shipments. For Ajanta, removal from the list requires documented corrective steps, successful reinspection, and clear proof the drugs meet safety standards.

This action does not automatically mean every batch was dangerous, but it signals serious regulatory concerns. Importers and pharmacies should expect supply delays. Hospitals and patients who rely on the product may need to find alternatives quickly.

What you can do

If you use Kamagra or handle it professionally, take a few practical steps: check with your pharmacist or supplier about current stock and lot numbers; do not use pills from questionable online sellers; report any side effects to your healthcare provider and to FDA MedWatch; ask your doctor for safe alternatives if your prescription is affected.

For pharmacies and distributors, confirm that your supplier has documentation showing the product was made at an inspected, compliant facility. If you import pharmaceuticals, work closely with customs brokers and legal advisors to understand the import alert and required paperwork for reentry.

Ajanta Pharma will need to correct manufacturing processes, train staff, and likely undergo a follow-up inspection. Until then regulators will keep a close watch. For consumers the safest move is to rely on regulated pharmacies and prescriptions rather than riskier online sources. If you're unsure whether a specific product lot is affected, ask your pharmacist for the batch number and cross-check with official FDA notices.

Timeframe for resolving an import alert varies. Some companies fix issues in a few months, others take longer if major facility upgrades are needed. Ajanta must submit a corrective action plan, then pass a reinspection. Importers and patients should watch FDA public notices or contact FDA's Division of Import Operations for updates. If you see suspect pills sold cheaply online, preserve packaging and report it — that helps regulators track unsafe supplies right away.

We’ll update this archive if Ajanta publishes corrective action plans or if the FDA changes the import status. For more detailed reports on pharmaceutical safety and regulation, check our main articles and subscribe for alerts.