NAFDAC Director-General, Prof Mojisola Adeyeye
ABUJA, Nigeria – The National Agency for Food and Drug Administration and Control has ordered the nationwide recall of two antibiotic suspensions produced by Sam-Ace Ltd after they failed laboratory testing for adequate active pharmaceutical ingredient (API) levels.
In Public Alert No. 34/2025, on Thursday, NAFDAC identified the affected products as Astamocil (Amoxicillin Suspension 125mg/5ml) Batch 826024, and Astamentin (Amoxicillin/Clavulanic Acid Suspension 228.5mg) Batches 0503024 and 0501724.
The products were discovered during a risk-based post-marketing surveillance operation at the Coordinated Wholesale Centre in Kano.
According to the agency, laboratory analysis confirmed that both medicines contained insufficient API, potentially compromising treatment effectiveness. “The company has been directed to recall the affected batches from circulation,” the statement read.
Amoxicillin and amoxicillin/clavulanic acid suspensions are commonly prescribed for respiratory, urinary tract, skin, and sinus infections. Substandard formulations may lead to treatment failure, prolonged illness, or antibiotic resistance.
NAFDAC urged health workers, pharmacies, and consumers to check batch numbers before dispensing or using. Suspected cases of poor-quality medicines should be reported through the agency’s hotline, 0800-162-3322, or via email at sf.alert@nafdac.gov.ng.
The agency emphasised that strengthening post-market surveillance remains essential to safeguarding public health and preventing circulation of falsified medicines.
