The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted healthcare providers, patients and the general public to the circulation of falsified and parallel-imported batches of Dostinex 0.5mg tablets in Nigeria.
In Public Alert No. 07/2026 on the surveillance and mop-up of counterfeit Dostinex (0.5mg) tablets, the agency identified three affected batch numbers GG3470, LG8659 and GG2440 with expiry dates of June 2027, January 2026 and April 2026, respectively.
The products, manufactured by Pfizer Italia S.R.L., were found circulating without a NAFDAC registration number.
According to NAFDAC, Pfizer Nigeria Ltd, the marketing authorisation holder, confirmed the presence of falsified and unregistered parallel-imported versions.
The company also clarified that although the legitimate product is registered, it has yet to be officially imported into Nigeria.
Dostinex 0.5mg is prescribed to reduce prolactin secretion and manage symptoms linked to excess prolactin levels.
NAFDAC warned that falsified, unlicensed and unregistered medicines pose significant public health risks because their quality, safety and efficacy cannot be guaranteed.
“The potency of products is highly dependent on complying with regulatory requirements,” the agency stated, noting that medicines not evaluated by NAFDAC may expose patients to treatment failure or adverse effects.
The agency directed its zonal directors and state coordinators to intensify surveillance and mop up the unregistered products wherever found.
Distributors, retailers and healthcare professionals were urged to exercise vigilance across the supply chain and ensure all medical products are sourced only from authorised and licensed suppliers.
Healthcare providers have also been advised to review stocks in hospitals, clinics and pharmacies and report any suspected falsified or compromised medicines to the nearest NAFDAC office. Reports can also be made via the agency’s hotline or through its online e-reporting platforms.
NAFDAC further encouraged patients and professionals to promptly report adverse drug reactions or side effects, reinforcing its commitment to safeguarding public health and ensuring regulatory compliance in Nigeria’s pharmaceutical market.
