Nearly 90K bottles of kids ibuprofen recalled from Indian company with troubled record

WASHINGTON — Nearly 90,000 bottles of children’s ibuprofen suspension have been recalled, according to the FDA.

It’s about more than just a recall for our team, as it ties into the work senior investigative reporter Lisa Fletcher has been doing for years, examining the risks associated with the bulk of America’s drugs being made in foreign countries like India.

The massive recall was triggered by complaints of a gel-like mass and black particles inside some bottles, raising questions about quality and safety.

Recall information:

• Children’s Ibuprofen Oral Suspension 100mg, sold in 4-ounce bottles, made by Strides Pharma and manufactured for Taro Pharmaceuticals USA.
• It involves Lot: 7261973A, 7261974A, with an expiration date of 01/31/2027.
• This is a Class II recall, meaning it could cause temporary or medically reversible health problems.

Take a look at the lot numbers and discard this product if you have it (Photo: SBG)

If you have this product, stop using it and contact your pharmacist or pediatrician.

For parents, it’s the kind of medicine you reach for without thinking, but it’s exactly the kind of product our team has been investigating for years: drugs made overseas in a system that can be hard to see and harder to police.

The FDA announced the recall this week (Photo: SBG)

The medicine is made by Strides Pharma Science, an India-based company. We already know the company has had issues with the FDA in the past, including problems with quality systems at some of its facilities. It’s consistent with what FDA inspectors said they see with Indian-made drugs on a regular basis.

We reached out to the company and posed a series of questions, including what quality control measures it has put into place, and the status of its investigation into this recall. We have yet to hear back.

We’re digging into the history of the manufacturer (Photo: SBG)

Former inspector Peter Baker has been sounding the alarm that problems in India’s facilities can translate to real risks for patients.

I think we got too comfortable with very low cost generic products and sort of ignored the red flags that had been arising from FDA and other regulators for a couple of decades now,” said Baker in a 2025 interview with us.

In the days ahead, we’ll be digging deeper into this company’s history, pulling FDA records and talking to inspectors who spent years in Indian drug manufacturing plants to help you better understand what’s going on behind the scenes.

To learn more, watch our half-hour special report below:

There’s a much bigger question that lies outside of just one recall, but centers on how much we really know about the drugs we trust.