NAFDAC Issues Alert as U.S. Recalls 90,000 Bottles of Children’s Ibuprofen

The National Agency for Food and Drug Administration and Control (NAFDAC) has notified Nigerians about the recall of nearly 90,000 bottles of Children’s Ibuprofen Oral Suspension in the United States over contamination concerns.

The agency said on Saturday that the U.S. Food and Drug Administration ordered the recall after reports indicated the presence of foreign substances in the medication.

NAFDAC explained that the manufacturer, Strides Pharma Inc., launched the recall after consumers reported discovering a “gel-like mass” and “black particles” inside the oral suspension.

The product, Children’s Ibuprofen Oral Suspension USP (100 mg/5 mL), is commonly prescribed for children to relieve pain caused by colds, flu, headaches, sore throats and toothaches.

According to NAFDAC, foreign materials in pharmaceutical products can compromise their safety, quality and therapeutic effectiveness.

The recalled medication was produced by Strides Pharma Inc. in India on behalf of Taro Pharmaceuticals in the United States and packaged in 120 mL bottles.

Affected batches bear lot numbers 7261973A and 7261974A and are due to expire on January 31, 2027.

While the products were only distributed within the U.S. market, NAFDAC said it is acting proactively to prevent their importation into Nigeria.

The agency stated that its zonal directors and state coordinators have been directed to intensify market surveillance and confiscate any affected products found in circulation.

It also advised importers, distributors, retailers, healthcare workers and caregivers to remain vigilant and refrain from handling or using the recalled medicine.

Healthcare facilities were urged to check their stock immediately and quarantine any affected batches.

“They should seek medical attention if any unusual reactions are observed in children who may have taken the medication,” NAFDAC said.

The agency encouraged the public and healthcare professionals to report adverse drug reactions through its official reporting platforms and reiterated its commitment to safeguarding public health through robust regulatory oversight.

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