If your child has been taking Children's Ibuprofen, you might want to check the bottle right now.

NAFDAC has alerted Nigerians to a recall of about 90,000 bottles of Children's Ibuprofen Oral Suspension in the United States. The US Food and Drug Administration (USFDA) ordered the recall after consumers found a "gel-like mass" and "black particles" floating inside the medication.

The product — Children's Ibuprofen Oral Suspension, USP (100 mg/5 mL) — is commonly used to bring down fevers and ease pain from colds, flu, sore throats, headaches, and toothaches in children. The affected bottles are four-fluid-ounce (120 mL) size, manufactured by Strides Pharma Inc. in India for Taro Pharmaceuticals in the US.

Only two lot numbers are affected: 7261973A and 7261974A, both with an expiry date of January 31, 2027. The recall was initiated by Strides Pharma after consumers reported the foreign material.

Although the medication was distributed and recalled within the US, NAFDAC says it isn't taking chances. The agency has directed all its zonal directors and state coordinators to ramp up surveillance and seize any affected products found in Nigeria.

"Healthcare professionals and members of the public are encouraged to report adverse events associated with medicinal products through its reporting platforms or the nearest NAFDAC office," the agency said in a statement on its X handle on Saturday.

NAFDAC also warned importers, distributors, retailers, and caregivers to stop importing, selling, or using the recalled batches. Healthcare facilities have been told to check their inventories immediately and quarantine any affected bottles.

For parents who may already have bought the product, NAFDAC's advice is clear: stop using it. If your child has taken the medication and shows any unusual reactions, seek medical help right away.

The presence of foreign materials in medicine can compromise its quality, safety, and effectiveness. Ingesting particles like those reported — gel-like masses or black specks — could cause choking, irritation, or other health problems, especially in young children.

This isn't the first time Strides Pharma has faced quality issues. The Indian manufacturer has had past recalls for similar contamination problems, though this latest one targets the US market specifically.

NAFDAC hasn't confirmed whether any of the recalled bottles have entered Nigeria, but the agency says it's staying ahead of the problem through continuous monitoring.

  • Product: Children's Ibuprofen Oral Suspension, USP (100 mg/5 mL)
  • Bottle size: 4 fl. oz. (120 mL)
  • Manufacturer: Strides Pharma Inc., India (for Taro Pharmaceuticals, US)
  • Lot numbers: 7261973A and 7261974A
  • Expiry: January 31, 2027
  • Reason for recall: Foreign material (gel-like mass, black particles)
  • Total recalled: ~90,000 bottles
  • Action: NAFDAC has ordered intensified surveillance across Nigeria