By Mary Izuaka

 

The National Agency for Food and Drug Administration and Control (NAFDAC) said it has received a notification that the United States Food and Drug Administration (USFDA) has announced the recall of Children’s Ibuprofen Oral Suspension, USP (100 mg/5 mL) due to the presence of foreign material in the product.

NAFDAC disclosed this in a Public Alert No. 028/2026 titled ‘Recall of children’s Ibuprofen Oral Suspension in the United States due to potential contamination with foreign material’ published on its X handle on Saturday.

The agency said Strides Pharma Inc. initiated the recall following consumer complaints of a “gel-like mass” and “black particles” observed in the oral suspension.

Ibuprofen Oral Suspension, USP (100 mg/5 mL) is a medication for children, intended for pain relief from the common cold, flu, sore throat, headache, and toothache, and for reducing fever.

Potential Health Risks

NAFDAC said the presence of foreign material in medicinal products may compromise product quality, safety, and efficacy.

It explained that administration of contaminated oral suspensions may potentially result in adverse reactions, particularly in children, and may present choking or gastrointestinal risks depending on the nature of the contaminant.

The affected product, according to NAFDAC, is Children’s Ibuprofen Oral Suspension, USP 100mg/5mL, packaged in 4 fl. oz. (120 mL) bottles. Manufactured by Strides Pharma Inc., India (manufactured the product for Taro Pharmaceuticals U.S.A., Inc.)

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The agency said the recall covers two lot numbers: 7261973A and 7261974A with an expiry date of 31 January 2027.

“Quantity Recalled: Approximately 90,000 bottles distributed nationwide in the United States,” NAFDAC said.

However, the agency said the affected product was distributed and recalled within the United States.

“NAFDAC remains committed to safeguarding public health and will continue surveillance activities to ensure the quality, safety, and efficacy of medicines circulating in Nigeria and prevent the recalled products from entering the Nigerian supply chain through authorised or unauthorised channels.

“Healthcare professionals and consumers are advised to report any suspicion of the sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office, call 0800-162-3322, or send an email to sf.alert@nafdac.gov.ng.”