Viatris
The next recall is not the risk. Your response is.
In the pharmaceutical sector, product performance is the foundation of trust, but it is not what ultimately defines reputation. That moment comes when quality is called into question.
For Viatris, product safety events are not isolated technical issues. They are highly visible, time-sensitive moments, scrutinized by regulators, experienced by clinicians, and felt across the care pathways that depend on consistency and control.
In these moments, your response defines the brand.
Rising recall activity. Escalating consequences.
Over the past five years, recall activity across the U.S. pharmaceutical sector has remained consistently elevated. While 2025 aligns with the long-term average, this should not be mistaken for reduced risk. Instead, it reflects a sustained level of exposure that Viatris must continuously manage.
For Viatris, the implications are clear. Regulatory scrutiny continues to intensify, as the FDA and policymakers actively explore expanded authority over recall processes and enforcement. Expectations for speed, transparency and control are rising, creating a more demanding risk environment where recall readiness, execution and governance standards continue to tighten.
The anomalous spike in 2023 was driven by a single, exceptional sterility incident identified through FDA inspection at a manufacturing facility – resulting in nearly 100 events. Excluding this outlier it reveals a more instructive reality: recall activity persists at scale, year after year, rather than fluctuating over time.
A broader risk landscape facing Viatris.
Pharmaceutical recalls are rarely driven by a single point of failure, they emerge across a wide range of factors, creating a persistent state of exposure. This breadth is not new. What has changed is the frequency with which these issues are surfacing, and the pace at which they must be addressed.
For Viatris, this creates a more demanding operating reality. Events that may begin as contained issues can quickly expand, cutting across regulatory requirements, operational processes, and the clinical environments in which products are used.
In this context, the defining question is not whether Viatris will face future recall events, but how effectively the organization can respond when it matters most.
Viatris’s recall risk profile: a signal of exposure
From 2021 to 2025, Viatris recorded 11 FDA recall events in the U.S., placing it among the more frequently impacted drug manufacturers. Within a peer group of leading organizations, this level of activity positions Viatris toward the upper end of the exposure range.
At this level of exposure, consistency becomes critical. Repeated engagement in recall execution elevates the importance of response models that are not only effective, but reliably repeatable under pressure. Over time, the ability to deliver controlled, coordinated outcomes across successive events becomes a defining factor in sustaining confidence among regulators, clinicians, and the wider care pathways in which Viatris’s products are embedded.
Viatris’s risk composition.
Viatris’s recall activity is distributed across multiple categories, with those illustrated below emerging as the most prevalent over the past five years. Together, they reflect where exposure most consistently manifests across the organization. This is not unusual, but it is revealing.
A risk profile of this nature indicates that exposure is not confined to a single failure point. Instead, it spans across Viatris’s product lifecycle, where issues can emerge from various sources but require a consistent response once identified. This places greater emphasis on cross-functional coordination. When risks originate across multiple domains, the ability to align regulatory, operational and communication responses becomes a defining factor that drives how events are managed and how the brand is protected.
For Viatris, the challenge is no longer centered on identifying risk.
It is about controlling and executing through it – consistently, at scale, and without disruption to the stakeholders who depend on continuity of care.
- Can response infrastructure scale rapidly without compromising accuracy or compliance?
- Are communication channels equipped to deliver clear, consistent guidance across diverse audiences?
- Can operational teams coordinate effectively across geographies, regulators, and care settings under time pressure?
These are not theoretical considerations. They are the factors that shape how a recall is experienced, and how Viatris is ultimately judged.
Protecting the pharmaceutical industry for 30+ years.
Pharmaceutical manufacturers operate in an environment of increasing complexity, global supply interdependence and heightened regulatory scrutiny, where product safety, precision and traceability must be delivered with absolute consistency.
Since 1995, Sedgwick has supported leading pharmaceutical companies through periods of heightened recall exposure — scaling patient and clinician engagement, strengthening regulatory compliance and safeguarding trust when it matters most.
From the first notification through to event close-out, we execute recalls with proven systems designed to minimize disruptions, protect operations, and strengthen brand integrity.
Proven recall leadership:
- Global delivery at scale: 150+ countries and 50+ languages supported
- Depth of experience: 8,000+ recall and remediation programmes successfully managed
- Proven market impact: 500M+ products safely removed from the market worldwide
- Established heritage: 30+ years of disciplined, regulator-aligned recall leadership
When a nationwide controlled substance recall triggered immediate regulatory and operational pressure
A recall involving 2 million Lorazepam blister packs rapidly escalated into a high-pressure regulatory event.
Following assay and impurity concerns, urgent action was required across pharmacies and healthcare providers nationwide. As a Schedule IV controlled substance, the recall demanded strict FDA and DEA compliance, detailed reconciliation and secure chain-of-custody controls.
Operational complexity intensified further as the recall expanded from 74 direct accounts to more than 2,200 downstream consignees, while product data had to be captured at the individual blister pack level.
Recognizing the scale and scrutiny of the event, the manufacturer engaged Sedgwick Recall to help restore control and support compliant execution.
Solution
The result
A conversation, when it’s useful
Every recall is different, but the pressures medical device manufacturers face are remarkably consistent. If you are considering how Viatris would manage stakeholder communication, operational surge, global logistics and regulatory expectations during a high-visibility event, a short conversation can help clarify what recall readiness looks like in practice.
When the time is right, we’re here. Request an introductory conversation with Ryan.
Ryan Gooley
Director of Business Development
Ryan brings more than 20 years of experience supporting medical device manufacturers through recalls, field corrective actions, and post-market product safety events. Having advised on more than 1,500 recalls, withdrawals, and market corrections, he helps organisations navigate situations when patient safety, compliance, and continuity of supply are at risk.
He has led large-scale remediation programmes involving devices used across clinical and consumer healthcare settings, supporting time-sensitive recovery, replacement, and stakeholder communication efforts. Ryan works with organisations to strengthen recall readiness and response strategies in alignment with evolving FDA expectations and post-market obligations.
His expertise spans recall execution, operational coordination, and crisis management, helping organisations mitigate exposure, maintain continuity, and preserve confidence among regulators, providers, and patients.
Get deeper insights with our Recall Index
For more than a decade, Sedgwick’s Recall Index report has set the benchmark for product safety intelligence — combining rigorous data analysis with an unbiased perspective on the emerging trends shaping the pharmaceutical risk landscape.
The latest edition examines the regulatory scrutiny, post-market realities and operational pressures influencing drug safety and recall activity, offering essential insight into how risk is evolving in 2026.
Download your copy now and discover why the Recall Index is trusted by pharmaceutical safety and risk leaders in more than 100 countries.
