Children's Ibuprofen Class II Recall - Foreign Substance
Summary
FDA has initiated Class II recall D-0390-2026 for Children's Ibuprofen Oral Suspension, USP (100 mg/5mL, 4 FL OZ bottle) manufactured by Strides Pharma Inc. The recall was issued due to confirmed presence of foreign substances, specifically gel-like masses and black particles detected in the product. The affected product was distributed nationwide and manufactured in India for Taro Pharmaceuticals U.S.A., Inc.
What changed
Strides Pharma Inc has recalled Children's Ibuprofen Oral Suspension (NDC 51672-5321-8) following customer complaints about a gel-like mass and black particles found in the medication. The Class II recall designation indicates temporary or reversible health consequences are possible if the contaminated product is consumed. The recall is currently ongoing with nationwide U.S. distribution.
Pharmaceutical manufacturers and distributors should immediately halt distribution of the affected product and verify their inventory. Retailers and pharmacies must remove the recalled bottles from shelves and notify consumers who may have purchased this specific NDC. Healthcare providers should advise patients to return the product to place of purchase and seek alternatives. The FDA openFDA Enforcement API provides the official case record for this recall.
What to do next
- Cease distribution of recalled Children's Ibuprofen Oral Suspension (NDC 51672-5321-8) immediately
- Remove affected product from retail shelves and pharmacy inventory
- Notify consumers who purchased the product and advise return to place of purchase
Penalties
Non-compliance with Class II recall procedures may result in FDA enforcement action including potential injunction or additional regulatory sanctions
Source document (simplified)
STRIDES PHARMA INC
Drug Recalls (Class II)
← All Drug Recalls (Class II) Class II D-0390-2026 · 20260325 · Ongoing
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.
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
Source: openFDA Enforcement API
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