NAFDAC Clarifies List of 101 Withdrawn, Suspended, and Cancelled Drugs

• NAFDAC has clarified the status of 101 drugs recently withdrawn, suspended, or cancelled, saying the move aims to protect public health and prevent circulation of unsafe medicines across Nigeria.

The National Agency for Food and Drug Administration and Control (NAFDAC) has clarified the status of 101 drugs recently listed as withdrawn, suspended, or cancelled.

In a statement released Tuesday via its official X handle, the agency explained that the update aims to guide the public and healthcare stakeholders on the status and regulatory implications of each category.

According to NAFDAC, the classifications represent distinct regulatory actions:

• Withdrawn: Products voluntarily discontinued by manufacturers, often for market or commercial reasons.
• Suspended: Products temporarily halted pending compliance with regulatory standards.
• Cancelled: Products whose approvals have been fully revoked due to safety, quality, or poor manufacturing practices.

NAFDAC said the move aligns with global best practices to prevent counterfeit circulation and protect public health.

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Among the affected products are Artemether/Lumefantrine 40mg/240mg Tablets, ASAQ (Artesunate Amodiaquine Winthrop) Tablets, and Flagyl Suspension and Tablets (400mg). Diabetes medications such as Januvia and Janumet were also listed as withdrawn, while Amaryl M Tablets and Amaryl M SR were voluntarily withdrawn by Sanofi Aventis Nigeria Ltd.

Reaffirming its commitment to safety, NAFDAC said it will continue post-market surveillance and regulatory enforcement to ensure only safe and effective medicines remain available in Nigeria.