90,000 bottles of Children's Ibuprofen recalled over contamination fears in U.S.

Nearly 90,000 bottles of Children's Ibuprofen Oral Suspension have been recalled in the U.S. due to contamination. The medication, made by Strides Pharma Inc. in India for Taro Pharmaceuticals, contains foreign particles, including black specks and a gel-like substance. Parents and carers have been advised to check their supplies after customer reports triggered the alert.

The recall was announced by the U.S. Food and Drug Administration (FDA) following complaints from consumers. Some found visible black particles and an unusual gel in the berry-flavoured liquid, which is meant for children aged 2 to 11. While the FDA has stated the risk of serious harm remains low, the contamination has raised concerns about manufacturing standards.

This is not the first recall for Strides Pharma Inc. Over the past two years, the company—along with its subsidiary Strides Pharma Global PTE. Ltd.—has withdrawn at least five products worldwide. Issues included subpotent drugs, stability failures, and particulate contamination. In January 2025, Ofloxacin Ophthalmic Solution was recalled in the U.S. for being weaker than required. Months earlier, in October 2024, Lidocaine HCl Injection failed stability tests. Three sterile injectables—Dexamethasone, Ondansetron, and Metoclopramide—were also flagged in September 2024 for containing particles. Neither Strides Pharma Inc. nor Taro Pharmaceuticals has responded to requests for comment on the latest recall.

The FDA's action removes the affected ibuprofen batches from circulation. Consumers holding the recalled product should stop using it and follow return instructions. The incident highlights the importance of strict quality controls, especially for medicines designed for young children.