Children's Ibuprofen Oral Suspension recall (STRIDES PHARMA INC)
DrugClass IIOngoing
Summary: STRIDES PHARMA INC is recalling Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, Made in India, NDC 51672-5321-8.. Reason: Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
What is being recalled
Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, Made in India, NDC 51672-5321-8.
Why
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
U.S.A. Nationwide
How to tell if yours is affected
Lot: 7261973A, 7261974A, Exp 01/31/2027
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0390-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 2, 2026 |
| Reported | March 25, 2026 |
| Company | STRIDES PHARMA INC |
| Company location | Bridgewater, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 89592 bottles |
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