THE UNITED REPUBLIC OF TANZANIA MINISTRY OF HEALTH TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

ISO 9001: 2015: CERTIFIED

PUBLIC NOTICE

24^th June, 2026

BAN ON THE USE OF VETERINARY MEDICINAL PRODUCTS CONTAINING LEVAMISOLE AS AN ACTIVE PHARMACEUTICAL INGREDIENT

1. The Tanzania Medicines and Medical Devices Authority (TMDA) would like to notify the general public, stakeholders in the livestock sector, and animal health professionals that it has conducted an assessment on the use and safety of veterinary medicinal products containing the Active Pharmaceutical Ingredient (API) namely Levamisole in the country.
2. Veterinary medicinal products containing this API were registered before to be used in the treatment and prevention of different types of worm infestations.
3. The current scientific evidence suggests that when animals are administered Levamisole in doses higher than recommended or used over a prolonged period of time, they tend to develop serious adverse events which include but not limited to excessive salivation, hyperesthesia (excessive sensory stimulation), muscle tremors, ataxia (loss of bodily coordination or staggering), head shaking, clonic convulsions (muscle rigidity and spasms), respiratory muscle paralysis, asphyxia (lack of oxygen) in severe cases and deaths.
4. Taking these serious adverse events into account and due to lack of good management of withdrawal periods once animals are given medications together with the risk of drug residues remaining in the food chain, the TMDA has decided to ban all veterinary medicinal products containing Levamisole as an API on the Tanzanian market.
5. Out of this regulatory action, all importers and distributors of affected products are directed to cease distribution and supply with effect from the date of this notice, and initiate the recall from the market within 14 days.
6. From now on, applications for registration of such products will not be accepted by TMDA and consequently, there will be no more permits issued for the manufacturing, importation, distribution or sale in the country.
7. Any livestock keeper, trader, or stakeholder currently in possession of medicinal products containing this API must immediately return them to TMDA headquarters or zone offices located in Arusha, Mbeya, Ruvuma, Tabora, Mwanza, Geita, Dar es Salaam, and Morogoro regions.
8. TMDA continues to execute its core mandate of protecting public health and the safety of livestock by ensuring that all medicinal products available on the market, meet the required standards of quality, safety, and efficacy.
9. This impending action is also in tandem with the principles underpinned in the One Health Approach.

Issued by:
Director General,
Tanzania Medicines and Medical Devices Authority
P.O. Box 1253, Dodoma.
Tel; +255 222 450512/658 445222/777 700002
Fax: +255 222450793
Email: info@tmda.go.tz
Website: www.tmda.go.tz