Nearly 90,000 bottles of children’s ibuprofen medicine sold nationwide were recalled, according to a report posted by the Food and Drug Administration (FDA) this week.

In a on March 16 recall notice, 89,592 bottles of Children’s Ibuprofen Oral Suspension in 100 milligrams (mg) per 5 milliliters (mL) were recalled earlier this month because the medicine could contain a foreign substance. The medicine is contained in 4 fl. oz bottles, manufactured in India for New York-based Taro Pharmaceuticals, and distributed to retailers nationwide, it said.

The company, India-based Strides Pharma Inc., initiated the recall on March 2. The company had “received complaints for a gel-like mass and black particles in the product,” the FDA said, also describing the recall as ongoing.

The recalled product was classified as Class II, which the FDA defines as a situation in which “use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

The products have an expiration date of Jan. 31, 2027, according to the notice. Lot numbers for the recalled products are: 7261973A and 7261974A.

It wasn’t clear whether there were any reports of injuries associated with the recalled medicine or how many complaints were submitted to the company.

No additional information on what consumers should do with the product was included in the report at this time, which is standard practice for FDA notices posted to its recall database.

The FDA notice added that a letter was sent out about the recall. However, it did not include a press release or other specific details.

The Epoch Times on Friday contacted Strides Pharma and Taro for additional comment but did not receive a response by publication time.

In 2019, the FDA sent a warning letter to Strides Pharma Science Inc., which does business as Strides Pharma Inc. in the United States, after FDA inspectors visited one of the company’s plants in India, saying that its “methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform” to the agency’s regulations and were in violation of federal law.

“Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products,” the FDA said at the time.

Later, in 2023, the FDA sent a letter to Strides stating that its investigators believe the company addressed the issues raised in the 2019 warning letter, but said the company must take steps to remain in compliance with FDA regulations.