Why it was recalled
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
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.
Lot numbers, UPCs & expiration codes
Lot: 7261973A, 7261974A, Exp 01/31/2027
Where it was sold
U.S.A. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0390-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 2, 2026
- FDA report date
- Mar 25, 2026
- Quantity
- 89592 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- STRIDES PHARMA INC
Original FDA data
Every field from FDA enforcement report D-0390-2026, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 98508
- Address
- 200 Crossing Blvd Ste 110
- Code information
- Lot: 7261973A, 7261974A, Exp 01/31/2027
- Postal code
- 08807-2861
- Report date
- Mar 25, 2026
- Product type
- Drugs
- Recall number
- D-0390-2026
- Classification
- Class II
- Recalling firm
- STRIDES PHARMA INC
- Product quantity
- 89592 bottles
- Reason for recall
- Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Mar 2, 2026
- Initial firm notification
- Letter
- Center classification date
- Mar 16, 2026