National Agency for Food and Drug Administration and Control Warns of Fake Dostinex Tablets in Circulation

The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public alert over the distribution of counterfeit and parallel-imported batches of Dostinex 0.5mg tablets in Nigeria.

In Public Alert No. 07/2026, the agency disclosed that three specific batch numbers—GG3470, LG8659 and GG2440—with expiry dates of June 2027, January 2026 and April 2026 respectively, have been identified in circulation without NAFDAC registration approval.

The affected product, manufactured by Pfizer Italia S.R.L., was discovered in the market without a valid NAFDAC registration number. NAFDAC stated that Pfizer Nigeria Ltd, the authorised marketing holder, confirmed the presence of falsified and unregistered parallel-imported versions. The company also clarified that although the genuine product is registered, it has not yet been officially imported into Nigeria.

Dostinex 0.5mg is commonly prescribed to treat conditions associated with elevated prolactin levels by reducing prolactin secretion.

NAFDAC cautioned that fake and unapproved medicines present serious health risks since their safety, quality and effectiveness cannot be assured. The agency stressed that products not evaluated and approved by NAFDAC could lead to treatment failure or harmful side effects.

As part of its response, NAFDAC has directed zonal directors and state coordinators to step up market surveillance and remove the unregistered products wherever they are found.

Healthcare providers, distributors and retailers have been advised to remain vigilant and source medicines strictly from licensed and authorised suppliers. Hospitals, pharmacies and clinics are also urged to review their inventories and report any suspicious or falsified products to the nearest NAFDAC office or through the agency’s hotline and online reporting channels.

NAFDAC further encouraged patients and medical professionals to promptly report any adverse drug reactions, reiterating its commitment to protecting public health and maintaining strict regulatory standards in Nigeria’s pharmaceutical sector.

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