NAFDAC Clarifies Status of 101 Withdrawn, Suspended, and Cancelled Drugs

On October 14, 2025, the National Agency for Food and Drug Administration and Control (NAFDAC) issued a public clarification regarding its recent list of 101 drugs that have been withdrawn, suspended, or cancelled. The agency explained that the move was aimed at protecting public health and ensuring transparency in regulatory decisions.

According to NAFDAC Director-General Prof. Mojisola Adeyeye, the term “withdrawn” refers to products voluntarily discontinued by manufacturers, often for commercial reasons rather than safety concerns. Examples include Artemether/Lumefantrine tablets by Healthline Limited and ASAQ tablets by Sanofi Aventis Nigeria Ltd.

Products marked as “suspended” are those whose registration has been temporarily halted due to non-compliance with regulatory standards. These may be reinstated if manufacturers meet the required conditions. “Cancelled” products, however, have had their registration completely revoked due to safety issues, poor manufacturing practices, or quality failures. These are no longer approved for manufacture, sale, or use in Nigeria.

Among the affected products are Flagyl Suspension and Tablets (400mg), which are no longer approved, although other Metronidazole formulations remain registered. Penicillin G Sodium Sandoz Powder was voluntarily withdrawn, while Elisa Eye Drops had its approval revoked. Diabetes medications such as Januvia, Janumet, and Amaryl M Tablets were withdrawn, along with Aprovasc, Coaprovel, and Abacavir Sulfate/Lamivudine tablets. Norditropin Growth Hormone Injectables and Insulin Injectables were delisted, and Cryomarex Rispens HVT Vaccine was removed following regulatory reviews.

NAFDAC also highlighted its intensified crackdown on counterfeit and expired drugs. In October, the agency destroyed over ₦15 billion worth of banned and expired products in Ibadan, including codeine syrups, Tramadol, Oxytocin, and expired vaccines. In Lagos, officials seized unregistered malaria drugs worth ₦1.2 billion and intercepted a container falsely labeled as Diclofenac. At the Trade Fair market, banned cosmetics and fake goods worth ₦1.5 billion were confiscated.