Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceutica
Summary
The FDA issued a Class II for Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bott by STRIDES PHARMA INC. Reason: Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product..
Details
Source
Drug Recall
External ID
D-0390-2026
Action Date
2026-03-25
Status
Ongoing
Category
drug
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/Code Info: Lot: 7261973A, 7261974A, Exp 01/31/2027
Quantity Affected: 89592 bottles
Reason for Recall
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Distribution
U.S.A. Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-02
Company
Bridgewater, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 46 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
STRIDES PHARMA INC has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (STRIDES PHARMA INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does STRIDES PHARMA INC have FDA actions?
STRIDES PHARMA INC has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0390-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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