Pharmaceutical
The world’s leading product recall company. Supporting the pharmaceutical sector since 1995.
THE EVOLVING RISK LANDSCAPE
We are proud to partner with 9/10 of the world’s leading pharmaceutical brands.
Pharmaceutical companies are faced with managing increasingly complex supply chains, heightened regulatory scrutiny and an ever-evolving risk landscape. As more independent labs, pharmacies and academic institutions take a larger role in monitoring product safety and quality, the risks to brands and reputations will increase. Companies need a clear and comprehensive plan that demonstrates their commitment to product safety and quality, strengthens quality systems to help forestall future crises, and maintains reputations with customers and market share.
Our solutions combine an industry-leading planning and implementation process with proven tools and expertise to enhance the speed and effectiveness of any product recall, market withdrawal, retrieval or in-market challenge.
Since 1995, we’ve partnered with the world’s leading pharmaceutical brands to develop, test and execute over 7,000 product recall and remediation programs across 100 countries and 50 languages.
Whether you’re planning for — or currently facing — a product recall, market withdrawal or any other in-market product incident, our experts are on hand to support you.
PHARMACEUTICAL PRODUCT RECALL
Protecting the world’s leading pharmaceutical brands since 1995.
Effective product recall management requires immediate access to pharmaceutical distribution lists in order to reach vast networks of retailers, pharmacies, medical providers and — most importantly — patients. Unfortunately, many manufacturers have gaps in their distribution networks, which can delay their recall response.
The notification, retrieval, processing, storage and disposal of recalled products are complex undertakings that require effective management of risks to minimize impacts, and safeguard patient health and brand integrity.
Sedgwick Brand Protection’s solutions provide a quality-driven processing infrastructure that includes state-of-the-art security, segregated storage of recalled product, advanced product handling equipment, and the surge capacity to assist clients in all steps of the pharmaceutical product lifecycle.
PRESCRIPTION DRUG RECALLS
Precision in prescription drug recalls: navigating safety and trust.
Despite rigorous clinical testing and stringent drug approval processes, prescription drug recalls persist. The pharmaceutical industry operates under immense scrutiny, where a single oversight can trigger class action litigation, unprecedented fines, or even imprisonment.
With pharmaceutical product recalls, there is no margin for error. This demands an unwavering commitment to precision and accountability to ensure public safety and uphold trust in the pharmaceutical supply chain.
For more than 25 years, we have expertly managed thousands of prescription drug recalls and market withdrawals, and expertly mastered complex and evolving regulatory guidelines. Today we are proud to partner with 9 out of the world’s leading 10 pharmaceutical brands – discover how we can support you.
OVER THE COUNTER DRUG RECALLS
Navigating complex consumer notification and removal challenges.
Over-the-counter drug manufacturers and retailers encounter the challenging responsibility of notifying consumers during a product recall. The extensive distribution and widespread use of these drugs add layers of complexity in the logistics of their retrieval. Since 1995 we have supported drug manufacturers and retailers in removing affected products from shelves and consumers’ homes with the speed and accuracy demanded by regulatory agencies.
Our product recall experts specialize in addressing operational hurdles, delivering essential drug recall services such as on-site product effectiveness checks, notification services, product processing, secure storage facilities, and mandated preparedness planning. Discover how we can support you.
ESSENTIAL INSIGHT
For over a decade, Sedgwick brand protection has published its quarterly Recall Index report. Downloaded in more than 100 countries, the Index has established itself as the definitive guide to pharmaceutical product safety. Access high-level insights below and download our latest edition in full.
U.S. PHARMACEUTICAL PRODUCT SAFETY & RECALL INSIGHTS
Quarter 2, 2024
The number of units impacted by FDA pharmaceutical product recalls decreased 51.2% from 9.30 million in Q1 2024 to 4.54 million in Q2. For context, there have only been five other quarters in the past 15 years with fewer units recalled. The number of events was also lower, dropping from 112 recalls in Q1 2024 to 93 events in Q2.
Failed specifications was the leading cause of pharmaceutical product recalls with 21 events. Sterility was the second-most common concern in Q2 2024, linked to 15 recalls.
Class I recalls decreased by 42.9%, from 21 events in Q1 to 12 in Q2. This quarter saw a total of 46,527 units impacted, representing a significant 99.1% reduction from the 5.32 million units classified as Class I in Q1.
Quarter 1, 2024
There was a 14.5% decrease in pharmaceutical product recalls, from 131 in Q4 2023 to 112 in Q1 2024. The number of recalled units fell by 46.3% from 17.31 million in Q4 to 9.30 million in Q1.
Failed specifications was the leading cause of pharmaceutical recalls with 26 events. Contamination was the second-most common concern in Q1 2024, linked to 21 product recalls.
In terms of volume, sterility issues impacted the most pharmaceutical units with 5.38 million. Contamination was second with 1.21 million units, of which 7.8% were connected to two recalls for benzene.
Quarter 4, 2023
Q4 2023 saw a 22.4% increase in pharmaceutical product recalls, growing from 107 events last quarter to 131 this quarter. The number of units also increased, rising 133.3% from 7.42 million in Q3 to 17.31 million in Q4.
Poor temperature control was the leading cause of pharmaceutical recalls with 40 events. This is the first time in over eight years that this has been the top concern. Failed specifications was the second-most common cause for pharmaceutical product recalls by event with 27.
The number of events rose for all classes of recall severity in Q4. The biggest change was for Class I recalls, which increased from eight events in Q3 to 26 in Q4.
Quarter 3, 2023
The number of pharmaceutical recalls in Q3 2023 dropped by 20.7% from Q2 2023 to 107 events. The number of units recalled decreased even more, going from 24.24 million units in Q2 to 7.42 million in Q3, representing a decline of 69.4%. Sterility was the leading cause of pharmaceutical recalls with 45 events, or 42.1% of total recalls. Sterility also had the most units recalled in Q3, with 4.10 million, or 55.2% of recalled units. There was only one recall in Q3 that impacted more than 1.00 million units.
Failed specifications were the second-most common cause for pharmaceutical recalls in Q3 2023, linked to 16 events. This concern was also tied to the second-highest number of units recalled with 1.50 million. cGMP deviations were third in terms of events with 13 recalls.
Both the number of recalls and the units impacted rose for Class I recalls. While the number of events only increased from seven to eight, the number of units impacted grew from 21,099 in Q2 to 692,869 in Q3. The number of recalls and units for Classes II and III were lower, with Class II units falling from 23.09 million in Q2 to 6.28 million in Q3.
EUROPEAN PHARMACEUTICAL PRODUCT SAFETY & RECALL INSIGHTS
Quarter 2, 2024
In Q2 2024, there were 69 pharmaceutical product recalls across the UK and EU. This is up 9.5% compared to 63 events in Q1 2024.
Failed specifications was the leading cause of pharmaceutical product recalls in Q2 2024. It was linked to 17 events, up from seven events in Q1 2024. Safety risks was second with 14 recalls.
The UK recorded the most notifications of any country in Q2 2024 with 14. Italy was second with 13, and Spain and France tied for third with 10 alerts each.
Quarter 1, 2024
In Q1 2024, there were 63 pharmaceutical product recalls across the UK and EU. This is down 3.1% compared to 65 events in Q4 2023 and marks the second-lowest quarterly recall figure recorded in the past three years.
Safety risks were the leading cause of pharmaceutical product recalls and were linked to 18 events this quarter, a decrease from 24 events in Q4 2023. Failed specifications and Manufacturing errors tied for the second-most common concern.
France remained the leading pharmaceutical recall notifier for the second consecutive quarter, issuing 12 alerts in Q1 2024, down from 16 last quarter. Spain was second with 11 recall notifications.
Quarter 4, 2023
In Q4 2023, there were 40.9% fewer pharmaceutical product recalls compared to Q3 2023. The final quarter of the year closed with 65 events, down from 110 in Q3. Only one quarter in the past three years has recorded fewer events (Q3 2022 with 60).
Having dominated European pharmaceutical product recall activity in 2023, safety risks closed the year with 24 events in Q4, marking a 9.1% uplift on the 22 events recorded in Q3. Mislabelling was the second-most cited reason for recall with seven events.
France issued the most pharmaceutical recall notifications, with 16 alerts in Q4 2023, down from 20 in the previous quarter. Germany was second with 15 recall notifications, and Spain was third with 13 alerts. The UK had six notifications this quarter compared to 19 in Q3.
Quarter 3, 2023
Pharmaceutical recalls across the EU and UK increased by 48.6% in Q3 2023 compared to Q2 2023. There were 110 events this quarter compared to 74 in the previous quarter.
Safety risks was the leading cause of pharmaceutical recalls and was linked to 22 events this quarter, down slightly from 30 events in Q2 2023. The second-most common concern was foreign materials/contamination with 19 events, followed by mislabelling with 15 events in Q3. Last quarter, only eight recalls were attributed to foreign materials/contamination, and five were tied to mislabelling.
Germany had the most notifications, issuing 22 alerts in Q3 2023, up from 10 last quarter. France was second with 20 notifications and the UK was third with 19. Portugal followed with 15 notifications in Q3.
PHARMACEUTICAL REMEDIATION
Streamlining returns processes for the pharmaceutical sector.
To effectively manage product returns, pharmaceutical companies need streamlined processes and a proven infrastructure. Our fully automated, in-house tracking and monitoring services simplify the returns process to effectively handle expired and nonperforming inventory, reduce human error, and increase processing efficiencies.
With fast returns processing and a focus on accurately applying each manufacturer’s specific return policy, Sedgwick’s brand protection solutions efficiently generate the data necessary for reimbursement.
Leveraging three decades of industry experience and expertise, our proven best practice strategies and executional proficiency provide comprehensive support to drug manufacturers
INDUSTRY-LEADING CALL CENTER SOLUTIONS
With Sedgwick Brand Protection, gain 24-7-365 access to a global team of brand ambassadors ready to field calls from concerned customers.
Our expertise extends beyond the handling and resolution of product recall inquiries, to encompass a wide range of business and drug related challenges – from market withdrawals, product safety alerts, corrective action programs, and much more. Since 1995 we have provided the pharmaceutical industry with:
- Instant on-demand support that adds flexibility and agility to existing customer engagement infrastructures, alleviating pressure on resources as call volumes surge – ensuring vital day-to-day business operations are not compromised.
- Scalability in size and duration, from short-term engagements to long-term programs in response to one-time product recalls or persistent issues. Flexibility on-demand – simply dial up and down as required.
Case study
How a potential benzene contamination led to a 4M+ unit recall of a ‘high-demand’ product.
Case study
Recalling 10M+ hand sanitizer products amid a pandemic-driven national lockdown.
Download our Recall Index
Essential insight and analysis for mitigating pharmaceutical product recall risk.
SEDGWICK BRAND PROTECTION
The world's leading product recall company
For over 25 years, companies of all sizes and sectors have trusted our expertise in preparing for and managing their product-related challenges. Since 1995, we’ve successfully managed more than 7,000 of the most sensitive and time-critical product recall programs, spanning 100 countries and 50 languages.
Whether your in-house teams need scalability to maintain daily operations during a product crisis, or you require a complete end-to-end product recall solution, we have the experience to protect your brand and peace of mind.
If you’re currently facing a product recall, or seeking to enhance your recall readiness, contact us now.
About us
Since 1995, we’ve helped the world’s leading brands uphold their commitments of product safety to customers, supply chain partners and regulators. Our unrivalled experience spans more than 7,000 of the most sensitive and time-critical recall events, in over 100 countries and 50 languages. Discover more.
Industry-leading solutions
From product recall readiness audits and mock recall simulations, to complete turn-key withdrawal, retrieval, and remediation solutions – including regulatory guidance and reporting, we have the experience and resources to help manage your product wherever it is in market. Discover more.
Essential product safety insight
Featuring unrivalled analysis and perspective on the latest product safety regulation and recall trends, the Index report is the definitive guide to help mitigate recall risk, litigation, and reputational damage caused by product crises and in-market events. Downloaded in over 100 countries – get your copy now.
CONTACT US
CONTACT US
Whether you’re planning for — or currently facing — a product recall, market withdrawal, or any other in-market product incident, our experts are on hand to support you.