NAFDAC Pulls Contaminated Cough Syrup off Shelves—Batch Numbers

When a national drug regulator pulls a popular paediatric cough syrup off the market, the stakes are massive—not just for public health, but also for public trust. In this case, NAFDAC’s response was prompt, multi-layered, and coordinated, reflecting the urgency of the threat and the agency’s evolving role as a frontline defender of medicine safety in Nigeria.

Immediate Regulatory Action

Once NAFDAC’s central laboratory confirmed the presence of diethylene glycol in the affected batches of Benylin Paediatric Syrup, the agency issued an official Product Recall Alert (No. 013/2024) on April 10, 2024. The alert publicly listed:

Product details:

– Product Name: Benylin Paediatric Syrup
– Batch Numbers: 329303 and 329304
– Manufacture Date: May 2021
– Expiry Date: April 2024
– Importer: Johnson & Johnson West Africa
– Manufacturer: Johnson & Johnson (Pty) Ltd., South Africa

This announcement was shared across:

Communication channels:

– The NAFDAC website
– Traditional media (radio, TV, newspapers)
– Social media platforms
– Direct communication with importers, distributors, and healthcare institutions

NAFDAC also issued instructions to the public and healthcare providers to immediately stop administering the syrup and report any adverse effects.

Product Trace and Recovery

NAFDAC activated its Pharmacovigilance and Post-Marketing Surveillance Directorate, which is responsible for tracking substandard or falsified medicines in circulation. Field officers were dispatched nationwide to:

Actions taken:

– Inspect pharmacies, hospitals, and retail outlets
– Remove the affected product from shelves
– Collect samples for further analysis
– Document and trace supply chains from importer to end-user

By late April, NAFDAC reported that over 70% of the affected batches had been successfully recovered from the market, particularly in urban areas where regulatory reach is stronger.

Cross-Border Notification and WHO Engagement

In line with international best practices, NAFDAC notified:

Notifications to:

– The World Health Organization (WHO) under the Global Surveillance and Monitoring System (GSMS)
– Regional regulatory counterparts in South Africa, Kenya, Ghana, and others
– Customs and border agencies to prevent further importation

This global cooperation ensured consistency in recall actions and made it harder for the contaminated product to circulate under the radar in neighbouring countries.

Public Assurance and Risk Communication

In the wake of panic and misinformation circulating on social media, NAFDAC’s Director General, Prof. Mojisola Adeyeye, held a press conference to address the nation. She emphasized that:

Key messages:

– No confirmed child deaths had been linked to the contaminated batches in Nigeria
– The agency was monitoring hospitals for any related adverse drug reactions
– NAFDAC was committed to full transparency and international collaboration

NAFDAC also set up toll-free lines, emergency contact centres, and WhatsApp hotlines to allow consumers and healthcare workers to report stock sightings or side effects.

Strengthening the Oversight Framework

Beyond the immediate recall, NAFDAC announced plans to:

Future plans include:

– Tighten import regulations, particularly for raw ingredients like glycerin and propylene glycol
– Mandate full traceability documentation from manufacturers, including Certificates of Analysis for every batch
– Increase random sampling and testing frequency of pediatric syrups and over-the-counter drugs

These actions aim to shift the system from reactive to proactive—catching potential contaminants before they reach consumers, not after.

NAFDAC’s response demonstrates a critical maturity in crisis management. But it also reveals the urgent need for more systemic reforms in medicine importation, laboratory testing, and manufacturer accountability.

Accountability and Response from Manufacturer and Importers

When a toxic contaminant is found in a drug that bears the name of one of the world’s largest pharmaceutical companies, the public expects more than silence. In the wake of NAFDAC’s recall, the attention quickly shifted to Johnson & Johnson (Pty) Ltd., South Africa, the manufacturer of the contaminated Benylin Paediatric Syrup. The company, along with its importers, health agencies, and international bodies, came under scrutiny not just for how the issue occurred—but how they chose to respond.

Johnson & Johnson’s Initial Silence

Initially, Johnson & Johnson (Pty) Ltd. did not issue a public statement in response to NAFDAC’s recall. The lack of a clear, public-facing explanation from the manufacturer raised eyebrows. The delay in communication stood in stark contrast to public health expectations—especially considering this wasn’t an obscure generic drug, but a mainstream, household name medicine trusted by parents and hospitals alike.

Despite multiple press inquiries, the company chose to remain quiet, leaving regulatory agencies like NAFDAC and SAHPRA (South Africa’s drug authority) to field the public fallout. This silence gave the impression of deflection rather than

NAFDAC Pulls Contaminated Cough Syrup off Shelves—Batch Numbers

Immediate Regulatory Action

Product details:

This announcement was shared across:

Communication channels:

– The NAFDAC website
– Traditional media (radio, TV, newspapers)
– Social media platforms
– Direct communication with importers, distributors, and healthcare institutions

NAFDAC also issued instructions to the public and healthcare providers to immediately stop administering the syrup and report any adverse effects.

Product Trace and Recovery

Actions taken:

By late April, NAFDAC reported that over 70% of the affected batches had been successfully recovered from the market, particularly in urban areas where regulatory reach is stronger.

Cross-Border Notification and WHO Engagement

In line with international best practices, NAFDAC notified:

Notifications to:

This global cooperation ensured consistency in recall actions and made it harder for the contaminated product to circulate under the radar in neighbouring countries.

Public Assurance and Risk Communication

In the wake of panic and misinformation circulating on social media, NAFDAC’s Director General, Prof. Mojisola Adeyeye, held a press conference to address the nation. She emphasized that:

Key messages:

NAFDAC also set up toll-free lines, emergency contact centres, and WhatsApp hotlines to allow consumers and healthcare workers to report stock sightings or side effects.

Strengthening the Oversight Framework

Beyond the immediate recall, NAFDAC announced plans to:

Future plans include:

These actions aim to shift the system from reactive to proactive—catching potential contaminants before they reach consumers, not after.

Accountability and Response from Manufacturer and Importers

Johnson & Johnson’s Initial Silence

Importer’s Role and Responsibility

The Nigerian importer—Johnson & Johnson West Africa—also failed to provide early public updates on how the contaminated batches entered the Nigerian market. No public recall notices, safety warnings, or consumer advisories were directly issued by the importer. This gap in accountability placed the burden of consumer protection squarely on NAFDAC.

This kind of passive posture is not uncommon in the global pharmaceutical industry, especially when products are distributed in less-regulated environments. But it reflects a worrying trend where multinational suppliers treat African markets with less urgency and transparency than they would in Europe or North America.

SAHPRA’s Investigative Findings

To its credit, the South African Health Products Regulatory Authority (SAHPRA) responded promptly by launching an investigation. They tested retained samples of Benylin Paediatric Syrup from the affected batches. Interestingly, their initial lab tests did not detect diethylene glycol, adding complexity to the situation.

Despite the negative findings, SAHPRA recommended a voluntary recall, demonstrating a precautionary approach. They also announced that further investigation into the raw materials and manufacturing process was ongoing. This move, although cautious, served to reassure the public that safety outweighed reputational risk.

WHO and International Involvement

The World Health Organization (WHO) was formally notified by NAFDAC and began monitoring the case under its Global Surveillance and Monitoring System. WHO had previously warned about similar cough syrup-related fatalities in countries like The Gambia, Indonesia, and Uzbekistan, all linked to DEG and ethylene glycol contamination.

While WHO did not issue an international alert specifically for Benylin, its continued involvement signaled to other regulators that this was not an isolated incident. WHO encouraged local agencies to increase quality surveillance, especially for paediatric syrups and imported liquid medicines.

Reactions from Health Advocacy Groups

Civil society and child health advocacy groups in Nigeria and across Africa were vocal about the recall. Organizations like the Society for Pediatric and Adolescent Medicine of Nigeria (SPAN) and Nigeria Health Watch called for:

Mandatory independent testing of all paediatric liquid medications.
Public disclosure of all test results by both regulators and manufacturers.
Stronger consumer education around drug recalls and adverse drug reactions.
Legal penalties for importers and manufacturers who violate product safety standards.

Their advocacy pointed out that without criminal or financial consequences, multinational drug manufacturers might continue treating African drug markets with a lower threshold of care.

In summary, while NAFDAC and other regulators acted swiftly, the muted response from the manufacturer and its West African subsidiary exposed glaring accountability gaps.

The Benylin Paediatric Syrup recall over diethylene glycol contamination is more than just a single-product safety issue—it exposes systemic weaknesses in pharmaceutical regulation, supply chain integrity, and public health safeguards across Africa. The incident has sparked important conversations and calls for reform at multiple levels.

Strengthening Pharmaceutical Regulation

Regulators like NAFDAC are increasingly viewed as gatekeepers of public safety, but their capacity remains challenged by:

Limited laboratory infrastructure: Advanced toxicology testing required to detect contaminants like DEG is costly and requires specialized skills. Many African countries rely on a handful of central labs with limited resources.
Gaps in supply chain oversight: Medicines often pass through multiple intermediaries before reaching consumers. Without robust tracking, contaminated products can circulate widely before detection.
Import and manufacturing inspections: Inspections of raw materials, especially those imported from overseas, are critical. Incidents like this highlight the need for mandatory, independent batch testing rather than sole reliance on manufacturer-supplied documentation.

NAFDAC’s recent measures—such as increasing post-market surveillance and enhancing import controls—are steps in the right direction, but sustained investment and international cooperation will be needed to elevate regulatory capacity.

Encouraging Local Pharmaceutical Production

The incident also raises the question of Africa’s dependence on imported medicines, particularly raw ingredients like glycerin and solvents. Encouraging and investing in local pharmaceutical manufacturing and quality control labs can reduce exposure to international supply chain vulnerabilities.

Countries such as Nigeria and South Africa have begun initiatives to promote local production, but progress remains slow due to funding, technology, and skills gaps.

Public Awareness and Consumer Empowerment

This recall underscores the importance of educating consumers on medication safety:

Understanding batch numbers and expiry dates
Recognizing recall notices
Reporting adverse drug reactions promptly to health authorities

Empowered consumers can be an effective first line of defense against harmful products.

Legal and Ethical Accountability

The absence of direct accountability from manufacturers and importers in this case has fueled demands for:

Stricter legal frameworks imposing financial penalties or criminal liability for companies responsible for distributing contaminated medicines.
Mandatory transparency laws requiring companies to publicly disclose batch testing results.
Improved whistleblower protections for employees who identify quality breaches.

Legislators and health advocacy groups are increasingly pushing for reforms to enforce corporate responsibility.

International Collaboration and Surveillance

The recall also demonstrates the need for stronger international mechanisms to detect, report, and manage substandard and falsified medicines. The WHO’s Global Surveillance and Monitoring System (GSMS) is crucial but requires expanded participation and timely data sharing among member states.

Bilateral and regional agreements could facilitate:

Joint inspections of manufacturing sites
Shared laboratory resources
Coordinated recall procedures

This would help close loopholes exploited by contaminated products crossing borders.

In essence, the Benylin syrup recall serves as a wake-up call. It reveals how fragile medicine safety can be when oversight falters and manufacturers evade accountability. It also shows the enormous work ahead in building resilient, transparent, and consumer-focused health systems across Africa.

While regulators and manufacturers work to resolve this crisis and prevent future ones, the reality is that you—whether as a parent, caregiver, or healthcare professional—need clear, actionable guidance to stay safe right now. Here are concrete measures everyone should take regarding cough syrups and other pediatric medications:

For Consumers and Parents

Check Your Medicine Batches:
Always examine the batch number and expiry date on any cough syrup bottle before purchase or use. For this recall, avoid using Benylin Paediatric Syrup with batch numbers 329303 or 329304.
Purchase from Reputable Sources:
Only buy medicines from licensed pharmacies or verified healthcare facilities. Avoid open markets, unregulated vendors, or unknown online sellers where counterfeit or contaminated products are more common.
Be Vigilant for Side Effects:
If your child has recently taken any cough syrup and begins to show symptoms such as vomiting, difficulty urinating, confusion, seizures, or extreme lethargy, seek medical attention immediately. Inform the healthcare provider about the specific medicine used.
Report Suspicious Products:
If you spot Benylin Paediatric Syrup with recalled batch numbers in stores or clinics, report it immediately to NAFDAC via their toll-free numbers or official social media channels.
Stay Informed:
Follow credible sources like NAFDAC, WHO, and your local health ministry for official updates about drug recalls or safety alerts.

For Healthcare Providers and Pharmacists

Inventory Check:
Conduct an immediate audit of your current medicine stock. Quarantine and remove any products from the recalled batches from your shelves or dispensaries.
Patient Education:
Inform parents and caregivers about the recall, symptoms of DEG poisoning, and when to seek urgent care.
Adverse Event Reporting:
Establish a robust system within your practice or hospital to monitor and report adverse drug reactions related to pediatric syrups to NAFDAC’s pharmacovigilance unit.
Source Verification:
Confirm that all imported medicines have valid documentation and certificates of analysis before procurement. Engage with trusted distributors who comply with regulatory standards.
Advocate for Training:
Encourage continued education for healthcare workers on detecting and managing drug poisoning cases, especially those involving contaminants like diethylene glycol.

By taking these immediate steps, consumers and healthcare providers become vital partners in the safety network—helping to identify dangerous products early and protect vulnerable populations, especially children, from harm.

The recall of contaminated Benylin Paediatric Syrup by NAFDAC serves as a critical lesson on multiple fronts—from regulatory vigilance to corporate accountability and consumer empowerment. While the incident exposed vulnerabilities in the pharmaceutical supply chain, it also illuminated the pathways for stronger, safer healthcare systems in Nigeria and beyond.

Key Takeaways

Regulatory agencies must be proactive and well-resourced. NAFDAC’s swift action showcased progress, but the need for enhanced laboratory capacity, rigorous import controls, and post-market surveillance remains urgent.
Manufacturers and importers must uphold uncompromising quality standards. The silent and delayed responses from Johnson & Johnson and its subsidiaries reveal accountability gaps that must be closed through enforceable laws and penalties.
Public awareness is indispensable. Consumers and healthcare providers equipped with the right knowledge form a critical frontline defense in identifying and reporting unsafe medicines.
International cooperation is essential. Medicine safety transcends borders; coordinated regulatory efforts, shared data, and harmonized recalls reduce risks posed by transnational pharmaceutical supply chains.

Moving Forward

Nigeria’s experience with this recall highlights the urgent need to invest in:

Local pharmaceutical production and quality assurance to reduce reliance on imported raw materials vulnerable to contamination.
Digital tracking systems for medicine supply chains to ensure transparency and traceability from manufacturer to patient.
Robust legal frameworks that mandate swift disclosure and punitive actions against companies that compromise drug safety.

As Nigeria and African countries advance these reforms, the goal remains clear: no child should ever be endangered by a medicine meant to heal. Ensuring safe, effective, and trusted medicines is not just a regulatory challenge—it’s a moral imperative.

If you’re a parent, caregiver, or healthcare professional, stay vigilant. Check your medicines, ask questions, and don’t hesitate to report concerns to NAFDAC or trusted health authorities. Together, informed and proactive communities can help build a safer health future for all.

NAFDAC Pulls Contaminated Cough Syrup off Shelves—Batch Numbers

Immediate Regulatory Action

Product details:

Communication channels:

Product Trace and Recovery

Actions taken:

Cross-Border Notification and WHO Engagement

Notifications to:

Public Assurance and Risk Communication

Key messages:

Strengthening the Oversight Framework

Future plans include:

Accountability and Response from Manufacturer and Importers

Johnson & Johnson’s Initial Silence

NAFDAC Pulls Contaminated Cough Syrup off Shelves—Batch Numbers

Immediate Regulatory Action

Product details:

Communication channels:

Product Trace and Recovery

Actions taken:

Cross-Border Notification and WHO Engagement

Notifications to:

Public Assurance and Risk Communication

Key messages:

Strengthening the Oversight Framework

Future plans include:

Accountability and Response from Manufacturer and Importers

Johnson & Johnson’s Initial Silence

Importer’s Role and Responsibility

SAHPRA’s Investigative Findings

WHO and International Involvement

Reactions from Health Advocacy Groups

Strengthening Pharmaceutical Regulation

Encouraging Local Pharmaceutical Production

Public Awareness and Consumer Empowerment

Legal and Ethical Accountability

International Collaboration and Surveillance

For Consumers and Parents

For Healthcare Providers and Pharmacists

Key Takeaways

Moving Forward

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