The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public health warning following the recall of nearly 90,000 bottles of Children's Ibuprofen Oral Suspension in the United States over contamination concerns.
The agency disclosed the development in a statement shared on its official X account, warning Nigerians, healthcare providers and drug distributors to remain vigilant against the affected medication entering the Nigerian market.
Why the children’s drug was recalled
According to NAFDAC, the recall was initiated by the United States Food and Drug Administration (USFDA) after consumers reported unusual foreign materials inside the medication. The manufacturer, Strides Pharma Inc., reportedly received complaints about a “gel-like mass” and “black particles” in the oral suspension, prompting an urgent recall.
The affected medicine, Children’s Ibuprofen Oral Suspension USP (100 mg/5 mL), is commonly used to treat fever, headaches, sore throat, toothaches and body pain associated with cold and flu in children. Health authorities warned that the presence of foreign materials in medicines could affect the product’s safety, quality and effectiveness, potentially putting children at risk.
Details of the affected products
NAFDAC said the recalled products were packaged in four-fluid-ounce (120 mL) bottles and manufactured in India by Strides Pharma Inc. for Taro Pharmaceuticals in the United States. The agency identified the affected batches as lot numbers 7261973A and 7261974A, both carrying an expiry date of January 31, 2027.
Although the products were distributed only within the United States, NAFDAC said it was taking precautionary measures to ensure they do not enter Nigeria through unofficial supply channels.
NAFDAC intensifies surveillance nationwide
As part of its response, NAFDAC said all zonal directors and state coordinators across the country had been directed to strengthen surveillance and monitor pharmaceutical outlets for the recalled products. The agency also warned importers, distributors, retailers and healthcare professionals against importing, selling or distributing the affected medicine.
Hospitals, pharmacies and healthcare facilities were advised to immediately inspect their inventories and isolate any suspected batches discovered during routine checks.
Advice to parents and caregivers
NAFDAC urged parents and caregivers who may already have the affected medication to stop using it immediately. The agency advised that children who may have consumed the medicine and later show unusual symptoms or reactions should be taken for medical evaluation without delay.
Healthcare professionals and members of the public were also encouraged to report any adverse drug reactions or suspicious products through NAFDAC’s official reporting channels or the nearest agency office.
Commitment to public safety
NAFDAC reaffirmed its commitment to protecting public health through continuous monitoring and regulation of medicines circulating within the country. The agency noted that proactive alerts and swift regulatory actions remain critical in preventing unsafe pharmaceutical products from reaching Nigerian consumers, especially vulnerable children.
In a related development, NAFDAC earlier warned the public about the circulation of counterfeit and unregistered Cerelac Mixed Fruits and Wheat products in Lagos. In a statement shared on the agency's website, the agency said the alert followed a complaint received by Nestle Nigeria Plc, the authorised marketer of the product in Nigeria. According to NAFDAC, the complaint involved a suspected counterfeit product purportedly manufactured by Nestlé Spain, bearing Batch Code 308002910.
