The National Agency for Food and Drug Administration and Control (NAFDAC) has warned Nigerians about the recall of nearly 90,000 bottles of children’s Ibuprofen oral suspension in the United States following reports of contamination.
In a public alert issued via its official X account on Saturday, the agency disclosed that the affected medication was recalled by the United States Food and Drug Administration (USFDA) after consumers reported the presence of foreign materials in the product.
According to NAFDAC, the recall was initiated by pharmaceutical manufacturer Strides Pharma after users complained of finding a “gel-like mass” and “black particles” in the children’s oral suspension.
The product, Children’s Ibuprofen Oral Suspension USP (100 mg/5 mL), is commonly administered to children to relieve pain and reduce fever associated with conditions such as colds, flu, sore throat, headaches and toothaches.
NAFDAC cautioned that the presence of foreign substances in medicinal products could affect their quality, safety and effectiveness, potentially posing health risks to consumers.
The recalled products were packaged in four-fluid-ounce (120 mL) bottles and manufactured by Strides Pharma in India for Taro Pharmaceuticals in the United States.
The affected batches carry lot numbers 7261973A and 7261974A, with an expiry date of January 31, 2027.
Although the products were distributed and recalled within the United States, NAFDAC said it had taken precautionary steps to ensure they do not find their way into Nigeria.
To achieve this, the agency said it had directed all zonal directors and state coordinators to intensify surveillance activities and remove any affected products discovered in their areas of operation.
NAFDAC also urged importers, distributors, retailers, healthcare professionals and caregivers to exercise caution by avoiding the importation, sale, distribution or use of the recalled medicine.
Healthcare facilities across the country were advised to immediately review their inventories and isolate any affected batches found in stock.
The agency further advised parents and caregivers who may have the recalled products to stop using them and seek medical attention if children who consumed the medication develop unusual reactions.
NAFDAC encouraged healthcare professionals and members of the public to report any adverse reactions linked to medicinal products through its official reporting channels or the nearest agency office.
The regulator reiterated its commitment to protecting public health through continuous monitoring and surveillance of medicines in circulation across Nigeria.
