Ibuprofen Suspension
FDA Recall NDC 51672-5321
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Ibuprofen (NDC 51672-5321). A significant event, classified as Class II, was initiated on Mar 02, 2026 by Taro Pharmaceuticals U.s.a., Inc.. The reported reason for this action was: "Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Mar 02, 2026
Mar 25, 2026
89592 bottles
Recall Profile & Regulatory Data
Event ID
98508
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
STRIDES PHARMA INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
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.
Batch or Lot Expiration Information
Lot# Lot: 7261973A, 7261974A, Exp 01/31/2027
Affected Packages Involved in this Recall
51672-5321-8Product
51672-5321-1Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
