The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted Nigerians to a precautionary recall of certain Aptamil and Cow & Gate infant and follow-on milk formulas over concerns of possible contamination.
In a public notice published on its website, the agency disclosed that the recall was initiated due to potential contamination with cereulide, a toxin produced by the bacterium Bacillus cereus. The toxin is known to cause foodborne illnesses, including nausea and severe vomiting, particularly in infants and young children.
According to NAFDAC, the affected batches of Aptamil and Cow & Gate products were manufactured in Ireland and Hungary and distributed across the European Union, the United Kingdom, and other countries. The agency, however, clarified that the recall does not affect Aptamil products produced specifically for Nigeria, which it said meet Codex standards and are safe for consumption.
“The precautionary recall of Aptamil 1 From Birth First Infant Milk and Follow-on Milk formula by Danone Nutricia is due to potential contamination with cereulide. Cereulide is a toxin produced by the bacterium, Bacillus cereus, known to cause foodborne illness and may cause symptoms such as nausea and severe vomiting.
“Exposure to toxins in infant and follow-on formulas may result in adverse health effects, including but not limited to gastrointestinal disturbances, growth and developmental concerns, as well as other toxicological effects, especially in infants and young children,” the agency stated.
The affected products include Aptamil 1 From Birth First Infant Milk (800g) with expiry date October 31, 2026; Cow & Gate 1 First Infant Milk (700g) with expiry dates ranging from July 31, 2026 to January 31, 2027; Cow & Gate 1 First Infant Milk Big Pack (1.2kg) with expiry dates between July 11, 2026 and February 20, 2027; Cow & Gate Anti-Reflux (800g) with expiry dates from June 7, 2026 to February 18, 2027; and Aptamil 2 Follow-On Milk (700g and 800g) with various batch dates up to February 20, 2027. Other pre-measured and big pack variants from both brands manufactured in Ireland and Hungary are also included in the recall.
NAFDAC directed all its Zonal Directors and State Coordinators to intensify surveillance, remove recalled or illegally imported products from circulation, and ensure that caregivers and healthcare providers source infant formulas only from authorised suppliers.
The agency emphasised that any product without the specified product information and NAFDAC registration number is illegal in Nigeria. The approved products include Aptamil Nutribiotik 1 (First Infant Milk) – D1-7392; Aptamil Nutribiotik 2 (Follow-On Milk 2) – D1-7396; and AptaJunior Nutribiotik 3 (Growing-Up Milk 3) – D1-7397.
Consumers were urged to report suspected availability of unregistered or illegally imported Aptamil and Cow & Gate products to the nearest NAFDAC office, through the agency’s e-reporting platforms, the Med-safety mobile application, or via email at pharmacovigilance@nafdac.gov.ng.
The alert comes amid a series of enforcement actions by the regulatory agency. Recently, NAFDAC flagged a suspected revalidated SMA Gold infant formula discovered in Kaduna State after altered expiry dates were reportedly linked to illness in a four-month-old infant. It also warned about the circulation of falsified Dostinex 0.5mg tablets in Nigeria, noting that while the legitimate product is registered, it has not yet been imported, and certain identified batches have no NAFDAC registration.
In Lagos, the agency intercepted counterfeit malaria medicines valued at over N1.2 billion concealed in a warehouse, while in Ibadan it destroyed expired and unwholesome medical products worth more than N15 billion as part of ongoing efforts to rid the market of harmful and falsified drugs.
