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Children's Ibuprofen Oral Suspension 100 mg/5mL
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DRUG RECALLMODERATE

Children's Ibuprofen Oral Suspension 100 mg/5mL

Taro Pharmaceuticals is recalling Children's Ibuprofen Oral Suspension 100 mg/5mL (120 mL) due to gel-like masses and black particles.

What to do

Stop using this product immediately. Do not give it to children. Contact Taro Pharmaceuticals or your healthcare provider if your child has consumed this product.

Recalled
Listed
Updated
Recall No.
D-0390-2026
Agency
FDA
Firm
STRIDES PHARMA INC
Recall ID
98508
Status
ONGOING

Recall at a glance

Quantity recalled
89592 bottles

Why it was recalled

Taro Pharmaceuticals is recalling Children's Ibuprofen Oral Suspension, USP, 100 mg per 5 mL, 4 FL OZ (120 mL) bottles (NDC 51672-5321-8) due to the presence of foreign substances including gel-like masses and black particles in the product. The affected product was manufactured in India and distributed nationwide.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

Children's Ibuprofen Oral Suspension, USP

Strength
100 mg
NDC / UPC
NDC 51672-5321-8

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated
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Editorial summary by Recall Canary · summary updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification