Parents and caregivers should check their medicine cabinets after a voluntary recall of a common children's pain reliever. Strides Pharma Inc. is recalling specific lots of Children's Ibuprofen Oral Suspension due to concerns about potential contamination.
What Is Being Recalled?
The recall affects 4-ounce (120-milliliter) bottles of Children's Ibuprofen Oral Suspension, USP (100 mg per 5 mL). These products were made for Taro Pharmaceuticals U.S.A. Inc. and distributed across the United States.
To see if your bottle is part of this recall, check the label for the following details:
- NDC number: 51672-5321-8
- Lot numbers: 7261973A or 7261974A
- Expiration date: 01/31/2027
Roughly 89,592 bottles are included in this recall.
Why Is This Recall Happening?
The company decided to pull these products from shelves after receiving complaints about "foreign substances" inside the bottles. Specifically, users reported finding a gel-like mass and black particles in the liquid medication.
Using a product that contains unknown particles or masses could pose a health risk, particularly for children. The FDA has categorized this as a Class II recall. The FDA uses this classification when a product may cause temporary or reversible health problems. While the risk of serious permanent harm is considered remote, the product does not meet safety standards and should not be used.
What Should You Do?
If you have a bottle that matches the lot numbers listed above, stop using it right away.
- Check the label: Look for the lot number and expiration date on the packaging.
- Consult your doctor: If your child has had any problems that may be related to taking this drug product, contact a health care provider.
- Report issues: You should report any adverse events or quality problems you've had with the use of this product to the FDA's MedWatch Adverse Event Reporting Program online, by regular mail, or by fax.
- Current status: This recall began on March 2, 2026, and the status is listed as ongoing.
How to Contact MedWatch
If you need to report a problem with this medication, you can reach the FDA's MedWatch program at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088).
