Regulator acts after whistleblower exposes manufacturing flaws
Several batches of Citro-Soda Regular have been recalled from the South African market after inspectors uncovered potential contamination at the Adcock Ingram production plant in Clayville, Johannesburg. The South African Health Products Regulatory Authority (SAHPRA) confirmed that the affected products include the 60g, 120g, and 4g sachet variants bearing batch numbers beginning with the letter "C," all of which were manufactured at the Clayville site.
Products produced at alternative facilities, including those made in India, remain unaffected by the recall and are considered safe for consumption.
The regulatory intervention was triggered by a whistleblower tip-off that led to an on-site inspection of the Clayville plant. Investigators discovered significant violations of Good Manufacturing Practice (GMP) standards, raising alarm bells about the safety of products leaving the facility.
SAHPRA CEO Dr Boitumelo Semete-Makokotlela announced the recall at a media briefing held in Pretoria on Tuesday, emphasising that the authority would not hesitate to act when public health is at stake.
"As a regulator, our mandate is to ensure that every health product you consume is of good quality, safe and effective...when we become aware of any details that indicates that there is any compromise of the quality, safety or efficacy of health products, we will act and we will do so decisively."
Lebohang Mazibuko, who heads SAHPRA's Inspectorate and Regulatory Compliance division, outlined the gravity of the findings during the briefing. Inspectors identified metal fragments shed by manufacturing vessels, along with unidentified black particles present on production equipment. Mazibuko stressed the serious health implications of such contamination.
"We found [the] presence of metal fragments from the manufacturer equipment and some unknown black particles from those manufacturing equipment. Those metal fragments were from the manufacturing vessels that are used to manufacture this product. Hence, we say you cannot consume a metal and be well after that."
Recall limited to specific Clayville batches
Beyond the metallic contamination, the inspection also revealed poor cleaning protocols, damaged and corroded equipment, and the lack of adequate air handling systems designed to prevent cross-contamination. These cumulative failures painted a troubling picture of manufacturing conditions at the facility.
SAHPRA was at pains to clarify that the recall applies solely to the identified Citro-Soda Regular batches from the Clayville plant and does not extend to other products in the Adcock Ingram range. Regulatory Compliance Manager Mokgadi Daphney Fafudi explained that the recall is being rolled out across all distribution channels, encompassing pharmacies, hospitals, clinics, and retail stores.
"The public needs to note that this is not a withdrawal of a product, but it's a recall of batches that do not comply, and these can be returned to the nearest facilities, whether it's a health facility or a retail facility. Otherwise, they can contact Adcock Ingram, the contact details are available on our website."
The regulator has called on consumers to check batch numbers carefully before purchasing Citro-Soda Regular and to report any quality defects they encounter with health products available in the country. Dr Semete-Makokotlela urged the public to play an active role in safeguarding product standards by alerting SAHPRA to any concerns they may have about the quality of health products on the market.
South Africans who regularly use Citro-Soda for digestive relief now face uncertainty about the safety of a trusted household product, particularly given that metal fragments and unidentified particles pose serious ingestion risks. For Adcock Ingram, the recall could erode consumer confidence and disrupt retail supply chains across pharmacies and clinics nationwide. The outcome of further inspections at the Clayville facility will likely determine whether production resumes or broader regulatory consequences follow.
