The Tanzania Medicines and Medical Devices Authority (TMDA) has announced an immediate ban on all human medicinal products containing Levamisole as the active pharmaceutical ingredient (API), citing serious safety concerns associated with the medicine.
The announcement, issued on 23 June 2026, follows routine pharmacovigilance activities conducted by TMDA to monitor the safety of medicines available in the country.
Why Has Levamisole Been Banned?
According to TMDA, safety reports collected from both local and international sources have identified a significant risk associated with Levamisole-containing medicines.
The Authority reported that Levamisole, commonly used in the treatment of worm infections, may cause Leukoencephalopathy, a serious neurological disorder affecting the brain’s white matter. If the condition is not diagnosed and treated promptly, it can lead to severe complications, including permanent neurological damage and death. Also, other countries including Nigeria and many more has banned Levamisole.
Following evaluation by the Vigilance Technical Committee (VTC), TMDA concluded that the risks associated with Levamisole outweigh its therapeutic benefits, prompting a nationwide regulatory ban.
What the Ban Means
Effective immediately, medicinal products containing Levamisole for human use are prohibited in Tanzania.
The ban applies to: Manufacturing, Importation, Distribution, Wholesale supply, Retail sale, Human use. All Healthcare facilities, pharmacies, wholesalers, distributors, and importers are required to stop handling these products immediately.
Mandatory Recall Within 14 Days
TMDA has instructed all importers and distributors to cease supplying Levamisole-containing medicines from the date of the announcement and complete a product recall within 14 days.
Failure to comply with regulatory directives may attract enforcement actions under the applicable medicines and medical devices legislation.
Advice to the Public
Members of the public who possess medicines containing Levamisole are advised not to continue using them.
Instead, they should surrender the medicines to the nearest TMDA office located in Dodoma, Arusha, Mbeya, Ruvuma, Tabora, Mwanza, Geita, Dar es Salaam and Morogoro.
Patients currently receiving treatment for intestinal worm infections should consult their healthcare provider or pharmacist for appropriate alternative medicines.
Role of Healthcare Professionals
TMDA urges healthcare professionals to support implementation of the directive by:
- Immediately discontinuing prescribing or dispensing Levamisole-containing medicines.
- Identifying and quarantining remaining stock.
- Informing patients about the recall.
- Reporting any suspected adverse drug reactions through the national pharmacovigilance system.
- Recommending safer alternative treatments where clinically appropriate.
TMDA Reaffirms Commitment to Medicine Safety
TMDA emphasized that protecting public health remains its core mandate by ensuring that all medicines available in Tanzania meet the required standards of quality, safety, and efficacy.
The Authority also encouraged healthcare professionals and members of the public to continue reporting suspected adverse drug reactions and medicine safety concerns to strengthen Tanzania’s pharmacovigilance system.
Our Perspective
The withdrawal of Levamisole-containing medicines highlights the importance of continuous post-marketing surveillance. Medicines that have been considered safe for many years may later reveal uncommon but serious adverse effects once used by larger populations.
Healthcare professionals should remain updated with regulatory safety communications and promptly implement changes in clinical practice to protect patients.
