Adcock Ingram’s Citro Soda recalled over contamination risk at Johannesburg plant

South Africa’s medicines regulator has assured the public it has no concerns about any other products made by pharmaceutical manufacturer Adcock Ingram in the wake of its recall of some of its Citro Soda products.

Citro Soda is one of Adcock Ingram’s signature brands. It is used to alleviate the symptoms of heartburn, indigestion and urinary tract infections and is widely sold in South Africa and neighbouring states.

The South African Health Products Regulatory Authority (Sahpra) issued a class 2 recall last week for Citro Soda made at Adcock Ingram’s Clayville plant in Johannesburg, after an inspection found deficiencies in its manufacturing processes that risked contamination with metal fragments, dust and cleaning chemicals.

Inspectors found damaged and rusty machinery, fragments of metal in manufacturing vessels, a damaged conveyor belt, residue on machinery and inadequate cleaning procedures, said Sahpra senior manager for inspectorate and regulatory compliance, Lebogang Mazibuko.

The regulator had not tested any of Citro Soda products for contaminants, as its inspection had found sufficient evidence that Adcock Ingram did not meet good manufacturing practice standards, she said.

A class 2 recall is issued for risks deemed to be temporary or reversible. A class 1 recall is issued for high-risk and potentially life-threatening problems.

Sahpra regularly issues product recalls and has pulled batches of several other medicines from the market in the past three months. These include batches of Glenmark Pharmaceuticals’ antibiotic supirobran antibiotic ointment, Cipla Medpro’s contrast agent urografin and Eurolab’s anti-nausea treatment Ondansetron, which were all issued with class 2 recalls.

No reports of adverse events associated with the use of Citro Soda had been reported to Sahpra, said CEO Boitumelo Semete-Makokotlela.

She said Sahpra’s action had been prompted by information it had received independently of the television show Carte Blanche, which aired an insert last month about alleged problems at its Clayville plant.

The recall only applies to batches of regular Citro Soda manufactured at the Clayville plant that expire on or before November 2027, which are identified by batch numbers starting with the letter C. The affected batches, which were destined for consumers in South Africa and nine other African countries, run to “tens of thousands” of units, said Mazibuko.

The recall does not affect regular Citro Soda manufactured at Adcock Ingram’s facility in Bangalore, India. Nor does it affect Citro Soda Cranberry.

Adcock Ingram does not report on the performance of individual products, but has consistently described Citro Soda as one of its top 10 non-prescription brands. It was the star performer in its digestive division, which generated sales of R460m in the year to June 2024.

About half these sales were attributable to Citro Soda, according to Adcock Ingram acting CEO Dorette Neethling.

Adcock Ingram was working closely with Sahpra to rectify the problems identified by the regulator and had temporarily closed the section of the Clayville plant that manufactured Citro Soda, she said.

Adcock Ingram’s review of the available information to date had not identified any consistent or emerging safety trends, and no specific or confirmed symptoms had been established in patients in relation to any potential contamination.

“Based on the data currently available, there is no evidence of impact to patient safety. However, ongoing monitoring and assessment continue, in line with regulatory requirements,” Neethling said.

Neethling expressed confidence that Adcock Ingram’s Bangalore site could increase production and meet demand for Citro Soda. Adcock Ingram had deliberately pursued a dual manufacturing strategy in which key products were made at more than one site, she said. Adcock Ingram sells more than a million units of Citro Soda a year, she said.

Adcock Ingram delisted from the JSE last year after selling a stake in the company to Indian generic company Natco.

Update 24 March 2026: This story was updated with comment from Adcock Ingram.