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FDA recall, , Moderate risk

Taro Children's Ibuprofen Oral Suspension

Children's Ibuprofen Oral Suspension contains a gel-like mass and black particles.

What happened

STRIDES PHARMA INC, of Bridgewater, New Jersey, 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, due to the presence of a foreign substance. The firm received complaints for a gel-like mass and black particles in the product. The recall began on March 2, 2026, and was added to the FDA's Enforcement Report on March 16, 2026.

The recalled product was distributed nationwide in the U.S.A.

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:

  1. Check the FDA or company notice for instructions specific to this product.
  2. Ask your pharmacist or doctor whether your lot is affected and what to do.

Is yours affected?

Match the NDC and lot code listed under your product.

An NDC (National Drug Code) is usually printed on the drug's label.

  1. NDC
    • 51672-5321-8
    Lot code
    • 7261973A
    • 7261974A

Recall details

Company began the recall
Sold in

U.S.A. Nationwide

Company
STRIDES PHARMA INCBridgewater, New Jersey
Risk

Moderate risk

Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.

FDA Class II recall · How risk is rated

Event ID
98508
Recall number
D-0390-2026
Quantity recalled
89592 bottles

All recalls from STRIDES PHARMA INC

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. In FDA's weekly enforcement report

  4. Listed on Recall Canary

  5. Summary updated

Summary by Recall Canary, written with AI · summary updated Oct 3, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)