Nigeria’s Drug Regulator Warns of Falsified GSK Augmentin Circulating in Pharmacies
Nigeria’s drug regulatory authority has issued an urgent public warning over the circulation of falsified Augmentin 625mg Tablets in the country.
The National Agency for Food and Drug Administration and Control (NAFDAC) announced on May 14 that it had received credible information from the marketing authorisation holder for GlaxoSmithKline (GSK) products confirming the presence of counterfeit versions of the widely used antibiotic.
According to the agency’s statement, the suspected counterfeit products carry Batch No. AC3N and are packaged in 2 x 7 tablets blisters. NAFDAC urged healthcare providers, pharmacies, and the general public to exercise extreme caution and immediately quarantine any stock bearing this batch number.
The alert comes amid growing concerns over the infiltration of substandard and falsified medicines into Nigeria’s supply chain, which pose serious risks to public health. The genuine manufacturer, GlaxoSmithKline, initiated the alert after receiving multiple complaints and reviewing documentary evidence, photographs, and video footage circulating on social media.
GSK’s investigation confirmed that while the batch number matches one previously supplied to Nigeria, the suspect samples contain inconsistencies that prove they are not authentic. Specifically, the falsified packs display manufacturing and expiry dates that do not align with GSK’s production records.
Detailed findings from the manufacturer’s probe reveal that the authentic Batch AC3N was manufactured on 23 August 2023 at GSK’s Worthing facility in the United Kingdom and packed between 19 and 20 September 2023. In contrast, the counterfeit versions carry a manufacturing date of September 2025 and an expiry date of September 2028. These dates are impossible because no batch with the number AC3N was produced in 2025.
Additionally, laboratory and packaging analysis identified textual errors on the labels and poor-quality fin seals, further confirming the products as falsified. Augmentin, which contains amoxicillin and clavulanic acid, is a commonly prescribed antibiotic used to treat various bacterial infections, including respiratory tract infections, urinary tract infections, and skin infections.
Health experts warn that falsified versions may contain incorrect amounts of active ingredients, no active ingredients at all, or even harmful contaminants. Patients using such products risk treatment failure, the development of antimicrobial resistance, and potential toxicity that could lead to severe health complications or death. NAFDAC has directed all healthcare professionals in hospitals, clinics, and retail pharmacies to conduct an immediate review of their stock.
Any suspected counterfeit Augmentin must be quarantined immediately, and its sale or distribution halted. The agency emphasised that only products from verified and authorised sources should be dispensed to patients. This latest incident highlights the persistent challenge of counterfeit medicines in Nigeria. Substandard and falsified drugs have long undermined public confidence in the healthcare system and contributed to treatment failures, especially for critical conditions requiring reliable antibiotics.
NAFDAC has intensified surveillance and collaboration with manufacturers, law enforcement agencies, and international partners to combat this menace. The agency has appealed to the public for vigilance.
Anyone who suspects they have purchased or encountered the falsified Augmentin is urged to report it immediately to the nearest NAFDAC office, call the toll-free hotline 0800-162-3322, or send an email to sf.alert@nafdac.gov.ng.
Prompt reporting will help authorities trace the source of the counterfeit products and prevent further distribution. Healthcare facilities and pharmacies across the country are expected to comply with NAFDAC’s directive without delay.
Members of the public who have recently purchased Augmentin with Batch No. AC3N are strongly advised to stop using it and seek guidance from their healthcare providers.
