Recalled children’s Ibuprofen prompts NAFDAC alert after US authorities recalled 90,000 bottles over foreign material contamination concerns

The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public alert following the recall of approximately 90,000 bottles of Children’s Ibuprofen Oral Suspension in the United States due to contamination concerns involving foreign material found in the product.

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NAFDAC said it received notification that the United States Food and Drug Administration (USFDA) announced the recall after consumers reported discovering a “gel-like mass” and “black particles” in the medication.

The affected product, 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, as well as to reduce fever.

According to the agency, the recall was initiated by Strides Pharma Inc., India, which manufactured the medicine for Taro Pharmaceuticals U.S.A., Inc.

The recalled batches are lot numbers 7261973A and 7261974A, packaged in 4 fl. oz. (120 mL) bottles, with an expiry date of January 31, 2027.

NAFDAC warned that the presence of foreign material in medicinal products could compromise their quality, safety and effectiveness.

The agency noted that administering contaminated oral suspensions may lead to adverse reactions in children and could pose choking or gastrointestinal risks depending on the nature of the contaminant.

Although the recalled products were distributed exclusively within the United States, NAFDAC said it is taking proactive measures to prevent the affected medicine from entering the Nigerian supply chain through authorised or unauthorised channels.

The agency disclosed that all zonal directors and state coordinators have been directed to intensify surveillance activities and remove the product from circulation if discovered in any part of the country.

NAFDAC urged importers, distributors, retailers, healthcare professionals and caregivers to remain vigilant and avoid the importation, sale, distribution or use of the affected batches.

The agency stressed that all medical products should be sourced only from authorised and licensed suppliers and that consumers should carefully examine the authenticity and physical condition of medicines before use.

Healthcare facilities and providers have also been advised to immediately inspect their inventories and quarantine any affected batches if identified.

Parents and caregivers who possess the recalled medicine, or who may have administered it to their children, were advised to discontinue use immediately and seek medical attention if any unusual symptoms or reactions occur.

As part of its ongoing pharmacovigilance efforts, NAFDAC encouraged healthcare professionals and members of the public to report any adverse reactions linked to medicinal products through its reporting channels, including its online platforms, the Med Safety mobile application, or directly through NAFDAC offices nationwide.

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The agency reaffirmed its commitment to protecting public health through continuous monitoring and regulatory oversight to ensure that only safe, effective and quality medicines remain available to Nigerians.