From paracetamol contamination to failing defibrillators, recent recall events show how fragile response mechanisms remain. Pete Gillett, founder of Marketpoint Recall, explores why life sciences firms must modernise recall operations before regulatory, financial and reputational costs spiral further.
In mid‑2025, Europe faced startling reminders of how fragile recall systems in life sciences remain.
In May, the UK’s MHRA initiated a Class 2 recall of Mercaptopurine 50 mg tablets due to microbial contamination, highlighting that even critical oncology drugs can pose patient risk when recall infrastructure lacks agility.
Just weeks later in July, a precautionary Class 2 recall was issued for Zaditen 0.25 mg/ml eye‑drops in the UK over potential microbial contamination. Over 11,000 packs of that specific batch had already been distributed before detection.
The truth is, recalls are a fact of life for pharmaceutical, medtech and biotech firms. What matters is how quickly and effectively organisations can act once a fault is discovered. Unfortunately, many still fall short because traditional recall systems, often made up of a patchwork of spreadsheets using data extracted from inflexible internal systems, are just not designed for today’s fast-moving, digitally connected world.
Why the cracks are widening
This is particularly critical in life sciences where supply chains are both vast and intricate. A single product may involve ingredients or components sourced globally, assembled across borders, packaged locally and distributed via multiple wholesalers before reaching pharmacies, hospitals or patients.
Tracking a fault across that chain is hard enough. Doing so while regulators, clinicians and patients demand real-time updates is close to impossible without modern systems. With patient safety paramount, the speed of communication between manufacturers, healthcare providers and patients is critical but varies wildly.
Some manufacturers can isolate and recover affected stock quickly while others struggle to trace which batches had gone where, or to notify end-users efficiently.
The cost of delay
The most obvious cost of an unprepared recall is financial. Delayed or incomplete responses can turn a limited product withdrawal into a multi-million-pound exercise. Stock must be destroyed, replacement products shipped, and compensation claims settled. Insurance can soften the blow, but premiums rise with each incident.
Then there are the regulatory implications. Both the MHRA and EMA have tightened their oversight of post-market surveillance and recall reporting. Firms that appear disorganised risk not only fines but also delays to future product approvals. For companies investing billions in R&D, that regulatory drag can be more damaging than the recall itself.
Reputation is harder to quantify but no less important. Patients and healthcare professionals are quick to lose confidence when firms appear evasive or slow to act. In life sciences, trust is hard-won and easily lost. A poorly managed recall can undo years of careful brand-building, particularly in competitive therapeutic areas.
Where current systems fall short
Three areas stand out where life sciences firms often struggle:
- Batch traceability: Too many organisations still rely on siloed manufacturing records or distributor logs. When a defect arises, it takes days rather than hours to pinpoint which patients or hospitals received which products.
- Stakeholder communications: Letters in the post or static notices in hospitals and doctors surgeries are no longer adequate. Regulators, clinicians and patients expect rapid, personalised updates via multiple channels.
- Cross-functional coordination: Quality, regulatory, legal, supply chain and communications teams often work in isolation. That slows decision-making precisely when every hour counts.
Building digital-first resilience
The good news is that recall management no longer needs to be a slow, manual scramble. Digital-first systems are emerging that can dramatically reduce cost and risk.
Cloud-based traceability platforms now allow firms to track ingredients and components through the entire supply chain, linking batch numbers directly to distributors, hospitals and even end-users. AI-driven contact tools can automate patient and clinician notifications at scale, reaching thousands of stakeholders within minutes rather than days. And singular monitoring dashboards provide leadership with real-time visibility of recall progress, ensuring nothing falls through the cracks.
These technologies are not futuristic luxuries. They are becoming essential to meeting the expectations of regulators and patients alike.
What recall ready looks like
Being “recall ready” is not just about tools. It requires a cultural and operational shift across the life sciences lifecycle.
In R&D, potential recall scenarios should be mapped at the design stage, with risk assessments considering not only product safety but also how faults could be traced and communicated. In manufacturing, digital batch coding and supply chain integration must become standard practice, ensuring instant traceability. In regulatory affairs, firms need processes for rapid reporting and two-way communication with bodies like the MHRA and EMA. In post-market surveillance, monitoring must extend beyond adverse event reporting to include real-world performance data and consumer feedback loops.
Ultimately, recall readiness is about embedding resilience across the organisation so that, when recalls inevitably occur, the response is controlled, transparent and cost-efficient.
A sector-wide imperative
Recalls will never disappear from life sciences. The products are too complex, the stakes too high and the risks too varied. What can, and must, change is how firms prepare for and execute them.
With regulators increasing their scrutiny, patients demanding transparency and costs spiralling, the sector cannot afford to rely on outdated processes. Modernising recall operations is not simply an operational upgrade. It is a critical safeguard for patient safety, a shield against financial and regulatory penalties and a foundation for long-term trust.
Life sciences firms that are recall ready will not prevent every incident. But they will respond faster, limit disruption and protect both patients and their own futures much better.
