Changeflow GovPing Pharma & Drug Safety Children's Ibuprofen Class II Recall - Foreign ...
Urgent Enforcement Added Final

Children's Ibuprofen Class II Recall - Foreign Substance

Favicon for changeflow.com FDA: Drug Recalls Class II
Filed March 25th, 2026
Detected April 7th, 2026
Email

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

  1. Cease distribution of recalled Children's Ibuprofen Oral Suspension (NDC 51672-5321-8) immediately
  2. Remove affected product from retail shelves and pharmacy inventory
  3. 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

CFR references

21 CFR Part 7

Named provisions

Recalls Subpart C - Recall Procedures

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
FDA
Filed
March 25th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
D-0390-2026

Who this affects

Applies to
Drug manufacturers Pharmaceutical companies Consumers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug Manufacturing Drug Distribution
Threshold
NDC 51672-5321-8, 4 FL OZ (120 mL) bottles of Children's Ibuprofen Oral Suspension
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Compliance frameworks
FDA 21 CFR Part 11 GxP
Topics
Product Safety Consumer Protection

Get Pharma & Drug Safety alerts

Weekly digest. AI-summarized, no noise.

Free. Unsubscribe anytime.

Get alerts for this source

We'll email you when FDA: Drug Recalls Class II publishes new changes.

Optional. Personalizes your daily digest.

Free. Unsubscribe anytime.