The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted healthcare providers, importers, distributors, and caregivers in Nigeria following the recall of about 90,000 bottles of Children’s Ibuprofen Oral Suspension in the United States over contamination concerns.
In a public safety alert issued on Saturday, the agency said it received notification from the United States Food and Drug Administration (FDA) regarding the recall, which was initiated after reports of foreign particles found in the product.
The manufacturer, Strides Pharma Inc., reportedly recalled the product after consumers in the U.S. reported the presence of a gel-like substance and black particles in the oral suspension.
Children’s Ibuprofen Oral Suspension (100 mg/5 mL) is commonly used in children to relieve pain associated with cold, flu, sore throat, headache, and toothache, as well as to reduce fever.
Health Risk Concerns
NAFDAC warned that contamination in medicinal products could compromise their quality, safety, and effectiveness.
It noted that the use of contaminated oral medications may pose health risks, particularly for children, including adverse reactions, choking hazards, or gastrointestinal complications depending on the nature of the foreign material.
Product Details
According to the agency, the affected product was manufactured by Strides Pharma Inc. in India for Taro Pharmaceuticals U.S.A., Inc.
The recalled batches are identified as lot numbers 7261973A and 7261974A, with an expiry date of 31 January 2027. The products were distributed across the United States before the recall was initiated.
Surveillance Measures in Nigeria
Although the recall was carried out in the United States, NAFDAC said it has activated precautionary measures to prevent the product from entering Nigeria through formal or informal distribution channels.
The agency directed its zonal directors and state coordinators to intensify surveillance and ensure immediate removal of any identified products from circulation.
It reaffirmed its commitment to protecting public health and ensuring that only safe, effective, and quality medicines are available in the Nigerian market.
Advisory to Stakeholders
NAFDAC advised importers, distributors, retailers, and healthcare professionals to source pharmaceutical products only from authorised and licensed suppliers.
Healthcare facilities were also urged to conduct immediate inventory checks and quarantine any affected batches if discovered.
Parents and caregivers in possession of the product were advised to discontinue use immediately and seek medical attention if any unusual reactions occur in children.
The agency further encouraged the public and healthcare professionals to report suspected adverse drug reactions through its pharmacovigilance reporting channels, including its e-reporting platform, Med Safety mobile application, nearest NAFDAC office, or official communication channels.
