The National Agency for Food and Drug Administration and Control (NAFDAC) has warned Nigerians about the recall of approximately 90,000 bottles of Children’s Ibuprofen Oral Suspension in the United States following contamination concerns.
In an announcement on its X handle on Saturday, NAFDAC said the United States Food and Drug Administration (USFDA) initiated the recall after consumers reported finding a “gel-like mass” and “black particles” in the medication. The product’s manufacturer, Strides Pharma, acted following those complaints.
The affected medicine – Children’s Ibuprofen Oral Suspension, USP (100 mg/5 mL) – is commonly used to relieve pain associated with colds, flu, sore throat, headaches and toothaches in children. NAFDAC warned that foreign materials in medicinal products can compromise their quality, safety and effectiveness.
The recalled batches were packaged in four-fluid-ounce (120 mL) bottles. They were manufactured by Strides Pharma in India for Taro Pharmaceuticals in the US. The lot numbers are 7261973A and 7261974A, with an expiry date of 31 January 2027.
Although the medication was distributed and recalled solely within the US, NAFDAC said it was taking proactive measures to prevent the products from entering the Nigerian market. The agency has directed all zonal directors and state coordinators to intensify surveillance and remove any affected products found in their jurisdictions.
NAFDAC advised importers, distributors, retailers, healthcare professionals and caregivers to remain vigilant and avoid the importation, sale, distribution or use of the recalled products. Healthcare facilities should inspect their inventories immediately and quarantine any affected batches.
Parents and caregivers in possession of the affected products should discontinue use immediately. “They should seek medical attention if any unusual reactions are observed in children who may have taken the medication,” NAFDAC said.
Healthcare professionals and members of the public are encouraged to report adverse events associated with medicinal products through NAFDAC’s official reporting platforms or the nearest NAFDAC office. The agency reaffirmed its commitment to safeguarding public health through continuous monitoring of medicines circulating in the country.
