Strides Pharma Inc. has voluntarily recalled approximately 89,592 bottles of Children’s Ibuprofen Oral Suspension nationwide after consumers reported finding a gel-like mass and black particles inside the medicine. The recall was initiated on March 2, 2026, and classified by the FDA on March 16, 2026, as a Class II recall — meaning use of the product may cause temporary or medically reversible adverse health consequences. No injuries or illnesses have been confirmed in connection with this recall.
What’s Being Recalled?
The recalled product is Children’s Ibuprofen Oral Suspension, USP, 100 mg per 5 mL, sold in 4 fl. oz. (120 mL) bottles. The product was manufactured by Strides Pharma Inc. for Taro Pharmaceuticals USA, Inc. and distributed to retailers nationwide. Only two lot numbers are affected: 7261973A and 7261974A, both with an expiration date of January 31, 2027. The recall number assigned by the FDA is D-0390-2026. The lot number and expiration date can be found printed on the bottle label.
Why Was This Product Recalled?
The recall was triggered after Strides Pharma received multiple consumer complaints describing a gel-like mass and black particles inside the liquid ibuprofen. The FDA has categorized these findings as the presence of a foreign substance — a contamination that should not be present in any medication, especially one intended for use in children. The FDA classified this recall at the Class II level, indicating that while exposure to the product may cause temporary or medically reversible health effects, the risk of serious adverse health consequences is considered remote. The source of the contamination has not been publicly disclosed.
What Should You Do?
If you have a bottle of Children’s Ibuprofen Oral Suspension in your medicine cabinet, check the lot number and expiration date on the label immediately. If your bottle carries lot number 7261973A or 7261974A with an expiration date of January 31, 2027, stop using it right away. Do not give the product to a child. Return the bottle to the retailer where it was purchased for a refund. If a child has already taken the recalled ibuprofen and you have concerns, contact your healthcare provider. Adverse events can also be reported to the FDA’s MedWatch program at fda.gov/safety/medwatch.
Source: https://www.foxbusiness.com/economy/bottles-childrens-ibuprofen-recalled-nationwide-fda-says
