Recalls / Class II
Class IID-0390-2026
Product
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.
- Brand name
- Ibuprofen
- Generic name
- Ibuprofen
- Active ingredient
- Ibuprofen
- Route
- Oral
- NDC
- 51672-5321
- FDA application
- ANDA211666
- Affected lot / code info
- Lot: 7261973A, 7261974A, Exp 01/31/2027
Why it was recalled
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Recalling firm
- Firm
- STRIDES PHARMA INC
- Manufacturer
- TARO PHARMACEUTICALS U.S.A., INC.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 200 Crossing Blvd Ste 110, N/A, Bridgewater, New Jersey 08807-2861
Distribution
- Quantity
- 89592 bottles
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2026-03-02
- FDA classified
- 2026-03-16
- Posted by FDA
- 2026-03-25
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0390-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.