NAFDAC Alerts Nigerians After US Recalls Contaminated Children’s Ibuprofen

The National Agency for Food and Drug Administration and Control NAFDAC has issued a public health alert following the recall of approximately 90,000 bottles of Children's Ibuprofen Oral Suspension in the United States over contamination concerns.

The agency said the recall was triggered after the United States Food and Drug Administration FDA received reports of foreign materials in the product, prompting manufacturer Strides Pharma Inc. to withdraw affected batches from circulation.

According to NAFDAC, consumers reported finding "gel-like masses" and "black particles" inside the oral suspension, raising concerns about the quality, safety and effectiveness of the medicine.

Children's Ibuprofen Oral Suspension, USP (100 mg/5 mL), is widely used to relieve pain associated with common childhood illnesses such as colds, flu, sore throat, headaches and toothaches, while also serving as a fever-reducing medication.

NAFDAC warned that the presence of foreign materials in medicinal products could pose serious health risks, particularly to children.

"The administration of contaminated oral suspensions may result in adverse reactions and could present choking or gastrointestinal hazards depending on the nature of the contaminant," the agency said.

The recalled product was manufactured in India by Strides Pharma Inc. for Taro Pharmaceuticals U.S.A., Inc. and packaged in 120ml bottles.

The affected batches are identified as Lot Numbers 7261973A and 7261974A, both carrying an expiry date of January 31, 2027.

Although the recall applies to products distributed within the United States, NAFDAC said it has activated precautionary measures to prevent the affected medication from entering the Nigerian market through authorised or unauthorised channels.

The agency disclosed that all zonal directors and state coordinators have been directed to intensify surveillance and remove the products from circulation if discovered anywhere in Nigeria.

NAFDAC also advised healthcare providers, pharmaceutical distributors, retailers and importers to source medicines only from licensed and authorised suppliers.

Healthcare facilities have been urged to inspect their inventories and immediately quarantine any affected products, while parents and caregivers who may have purchased or administered the medicine are advised to discontinue its use and seek medical attention if unusual reactions occur.

The agency reaffirmed its commitment to safeguarding public health through continuous monitoring and post-market surveillance of medicines in circulation.