D-0390-2026 Class II Ongoing
FDA drug recall D-0390-2026 was initiated by STRIDES PHARMA INC on Mar 2, 2026 and is designated Class II. Reason for recall: Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product. The recall status is ongoing. Affected quantity: 89592 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 25, 2026
- Initiation Date
- Mar 2, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 89592 bottles
Product Description
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 for Recall
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot: 7261973A, 7261974A, Exp 01/31/2027
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0390-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026