FDA recalls 90,000 bottles of children's ibuprofen over contamination fears
The U.S. Food and Drug Administration (FDA) has ordered a recall of nearly 90,000 bottles of Children's Ibuprofen Oral Suspension. The move follows customer reports of contaminants in the medication, including a gel-like substance and black particles. Manufactured in India by Strides Pharma Inc., the affected product is a berry-flavoured solution for children aged 2 to 11.
The recall began after several consumers noticed unusual particles in the liquid medicine. Strides Pharma Inc. acted quickly to pull the affected batches from shelves. The FDA has classified this as a precautionary measure, stating the risk of serious harm remains low.
This is not the first quality issue for Strides Pharma in recent years. In August 2025, the company recalled enalapril maleate tablets (20 mg, lots E25 and E26) in the US due to 'Failed Tablet Hardness' defects. The FDA categorised that incident as a Class II recall. No other contamination or quality problems were reported for their products between March 2024 and March 2026.
The latest recall highlights the importance of strict quality control for children's medications. The FDA continues to monitor drug safety, particularly for products intended for young patients. Strides Pharma Inc. has not reported any serious health incidents linked to the contaminated ibuprofen suspension.
