# Major Recall Alert: Darzalex (Daratumumab) Recalled Due to Unauthorized and Unregistered Formulation in Nigeria
The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a concerning public alert to Nigerians about the presence of an unauthorized and unregistered formulation of **Darzalex (Daratumumab)** being sold in the country. This is a regulated prescription medication, manufactured by **Johnson & Johnson**, that requires proper registration and quality assurances for its use.
Read on to understand why this recall is vital, the specifics of the situation, and how you can protect yourself and others from counterfeit or unauthorized medications.
## Why This Recall is Important
The sale of unauthorized or unregistered medicines poses a significant threat to public health and safety. Darzalex (Daratumumab), a monoclonal antibody therapy primarily used for treating multiple myeloma and other blood-related cancers, must adhere to stringent regulatory standards to ensure its safety, efficacy, and authenticity.
The unauthorized Daratumumab formulation circulating in Nigeria raises the following concerns:
- **Unknown Quality and Safety**: The unregistered product hasn’t undergone NAFDAC’s approval process, leaving its efficacy, sterility, and safety in question.
- **Risk to Cancer Patients**: As Darzalex is life-saving for individuals undergoing cancer treatment, substandard or falsified versions could lead to ineffective treatment or severe side effects.
- **Supply Chain Vulnerability**: Unregistered drugs could indicate gaps in pharmaceutical import and distribution practices that endanger the integrity of Nigeria’s healthcare system.
NAFDAC warns all stakeholders to remain vigilant and take immediate action to restrict the circulation of this illicit product.
## Details of the Recall
Here's what we know about the recall:
- **Category:** Unauthorized and unregistered drug sale in Nigeria
- **Brand:** Johnson & Johnson
- **Product Name:** Darzalex (Daratumumab)
- **Reason for Recall:** The presence of unauthorized and unregistered formulations being sold, bypassing regulatory health safeguards.
- **Announced By:** NAFDAC
- **Safety Advisory:** Prevent the importation, distribution, and sale of the unauthorized product within the supply chain. Report all suspicious or falsified medicines immediately.
- **Image of Product:**
For the official alert and further details, visit [NAFDAC’s website](https://nafdac.gov.ng/public-alert-no-031-2025-alert-on-the-presence-of-an-unauthorized-unregistered-darzalex-daratumumab-1800mg-15ml-vial-sc-injection-in-nigeria/).
## What You Should Do
If you are a consumer, healthcare provider, or part of the supply chain, here are some crucial steps to follow to prevent harm:
- **Verify Products Before Use**: Only purchase medications from reputable pharmacies and suppliers with NAFDAC-registered products.
- **Look for Warning Signs**: Check the packaging for registration details, product information, and proper labeling; report inconsistencies immediately.
- **Report Suspected Products**: Notify NAFDAC of any suspected counterfeit or unregistered medicines by contacting their customer support or using their official channels.
Healthcare professionals, in particular, should exercise extreme caution while prescribing or sourcing this medication to avoid administering potentially harmful counterfeit drugs.
## Stay Safe – Get Instant Recall Alerts
Your health and safety should always come first. To stay updated on recalls and regulatory alerts like this, download the **NAFDAC Mobile App** today. The app provides real-time notifications, enables users to confirm the authenticity of drugs, and allows reporting of suspicious products at the click of a button.
Stay informed and protect yourself and your loved ones with instant access to essential regulatory information.
For more information on this critical recall of **Darzalex (Daratumumab)**, visit the [official NAFDAC alert page](https://nafdac.gov.ng/public-alert-no-031-2025-alert-on-the-presence-of-an-unauthorized-unregistered-darzalex-daratumumab-1800mg-15ml-vial-sc-injection-in-nigeria/). Share this vital information to ensure that others remain informed and safe!