NAFDAC warns Nigerians about U.S. recall of children’s ibuprofen.

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

On Saturday, the agency posted on its X account that the United States Food and Drug Administration (USFDA) had recalled the product because it contained foreign material.

NAFDAC said the recall was initiated by Strides Pharma Inc., the manufacturer, after consumers reported a “gel‑like mass” and “black particles” in the oral suspension.

The Children’s Ibuprofen Oral Suspension, USP (100 mg/5 mL), is commonly used to relieve pain from colds, flu, sore throat, headaches and toothaches in children.

NAFDAC cautioned that foreign materials in medicines can compromise their quality, safety and effectiveness.

The affected products were packaged in four‑fluid‑ounce (120 mL) bottles and were produced by Strides Pharma Inc., India, for Taro Pharmaceuticals in the U.S.

Lot numbers of the recalled batches are 7261973A and 7261974A, with an expiry date of Jan. 31 2027.

Although the medication was distributed and recalled only in the U.S., NAFDAC said it is taking proactive steps to prevent the products from entering the Nigerian market.

The agency directed all zonal directors and state coordinators to intensify surveillance activities and remove any affected products found within their jurisdictions.

Importers, distributors, retailers, healthcare professionals and caregivers were advised to remain vigilant and avoid importing, selling, distributing or using the recalled products.

Healthcare facilities were urged to inspect their inventories immediately and quarantine any affected batches identified.

Parents and caregivers who possess the affected products were told to discontinue use.

“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 also encouraged to report adverse events associated with medicinal products through NAFDAC’s reporting platforms or at the nearest NAFDAC office.

NAFDAC reaffirmed its commitment to safeguarding public health through continuous monitoring of medicines circulating in the country.

(NAN)

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