IBUPROFEN
Recalling Firm / Manufacturer: STRIDES PHARMA INC
(Bridgewater, NJ, United States)
FDA Recall Number: D-0390-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
IBUPROFEN
Generic Name
IBUPROFEN
Active Substance(s)
Ibuprofen
Administration Route
Oral
National Drug Code (NDC)
51672-5321
Total Quantity Recalled
89592 bottles
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Full Product Description
Packaging specifications and labeling details
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.
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
March 25, 2026
Firm Initiation Date
March 02, 2026
FDA Classification Date
Mar 16, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot: 7261973A, 7261974A, Exp 01/31/2027
Distribution Information
Geographic scope of affected shipments
U.S.A. Nationwide
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0390-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508606UTCC