Moderate riskFDA DrugClass II

Strides Pharma children's ibuprofen recalled for foreign substance

Strides Pharma Children's Ibuprofen Oral Suspension (100 mg per 5 mL) has been recalled because some bottles contain gel-like masses and black particles. The affected bottles are 4 FL OZ (120 mL) size with lot numbers 7261973A or 7261974A, expiring 01/31/2027. No injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. Check if you have a bottle with lot number 7261973A or 7261974A
  2. Do not give this medication to your child
  3. Contact your pharmacist or doctor about a safe alternative pain reliever
  4. Dispose of the bottle safely

Is yours affected?

Compare your label or packaging with the recalled product.

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.
Sold in
Nationwide
Made for
Children (6 months to 12 years)

Details

Units affected
89592 bottles
Illnesses reported
None reported
Manufactured in
200 Crossing Blvd Ste 110, N/A, Bridgewater, NJ, United States
Classification
Class II
Recall number
D-0390-2026

In the FDA's words

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. Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product. Lot: 7261973A, 7261974A, Exp 01/31/2027 Distribution: U.S.A. Nationwide Affected quantity: 89592 bottles
Hazard
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.

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