RecallRadar
Free Check
omnipaquedrugHigh PriorityActive

GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.

GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63. was recalled because presence of particulate matter. If you have this product, stop using it until you verify your lot or model details.

By RecallRadar Editorial Team

Sourced from FDA. Last verified April 20, 2026.

On this page

Free checker

Check if you qualify

See whether your device may qualify for a free repair or replacement program before you spend money.

Check if you qualify

Key facts

Date announced
April 15, 2026
Source agency
FDA

This recall involves safety concerns. Take action promptly.

✨ Plain-English Summary

GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63. was recalled because presence of particulate matter. If you have this product, stop using it until you verify your lot or model details.

Is This Recall Still Active?

Status: Yes - Active

This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.

What's Being Recalled

Quoted source excerpt from the official notice.

Presence of particulate matter

Quick Info

Key facts from the official notice, kept in the article flow for easy cross-checking.

Brand
Omnipaque
Category
drug
Source agency
FDA
Announced
April 15, 2026
Country
US
Status
Active

Who's Affected

Specific models and identifiers listed in the source notice:

Model #1

Lot# 17225029; Exp. September 3, 2028 Lot# 17265376; Exp. October 3, 2028 Lot# 17270885; Exp. September 10, 2028 Lot# 17292246; Exp. October 4, 2028 Lot# 17301805; Exp. October 18, 2028 Lot# 17301807; Exp. September 7, 2028 Lot# 17301810; Exp. October 20, 2028 Lot# 17304992; Exp. October 5, 2028 Lot# 17304993; Exp. October 19, 2028 Lot# 17304996; Exp. November 25, 2028 Lot# 17321225; Exp. September 8, 2028 Lot# 17333589; Exp. November 24, 2028 Lot# 17333611; Exp. November 26. 2028 Lot# 17333613; Exp. November 23. 2028 Lot# 17357000; Exp. December 5, 2028 Lot# 17366399; Exp. December 14, 2028 Lot# 17376486; Exp. December 14, 2028 Lot# 17404114; Exp. December 6, 2028

Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.

What You Should Do

Follow the remedy path from the official notice using the exact model and serial details above.

  1. 1Stop using the affected product until you verify whether your item is impacted.
  2. 2Check the official recall notice and match your model, lot, or serial details.
  3. 3Follow the official instructions for repair, replacement, refund, or disposal.
Open Official Recall Notice

Source & Verification

This page summarizes the official notice and keeps key facts easy to verify.

Official source
FDA
Announced by source
April 15, 2026
Last reviewed by RecallRadar
April 20, 2026

Frequently Asked Questions

Am I affected by this recall?

Check the affected models section on this page. The official notice currently lists Lot# 17225029; Exp. September 3, 2028 Lot# 17265376; Exp. October 3, 2028 Lot# 17270885; Exp. September 10, 2028 Lot# 17292246; Exp. October 4, 2028 Lot# 17301805; Exp. October 18, 2028 Lot# 17301807; Exp. September 7, 2028 Lot# 17301810; Exp. October 20, 2028 Lot# 17304992; Exp. October 5, 2028 Lot# 17304993; Exp. October 19, 2028 Lot# 17304996; Exp. November 25, 2028 Lot# 17321225; Exp. September 8, 2028 Lot# 17333589; Exp. November 24, 2028 Lot# 17333611; Exp. November 26. 2028 Lot# 17333613; Exp. November 23. 2028 Lot# 17357000; Exp. December 5, 2028 Lot# 17366399; Exp. December 14, 2028 Lot# 17376486; Exp. December 14, 2028 Lot# 17404114; Exp. December 6, 2028.

What is the remedy for this recall?

Follow the official instructions for repair, replacement, refund, or disposal on the omnipaque recall page.

Where can I verify recall details?

Use the official source link in this page to confirm dates, eligibility, and next steps: https://api.fda.gov/drug/enforcement.json?search=recall_number:D-0447-2026&limit=1

Keep browsing with these internal hubs: omnipaque recall hub and Food & Drug recall hub.

Official Resources

Use these primary sources for final eligibility and claim instructions.

View official notice from FDA

See an inaccuracy?

Help us improve the accuracy of this recall information.

500 characters remaining

Related Recalls

Honeyville, inc
High PriorityActive

(BULK) SPL-BEV Banana CWT (Banana Smoothie); Super Sack Tote Item# 355-0099

Firm received and used potentially contaminated (Salmonella) ingredient to manufacture various products.

Jun 3, 2026

Legacy bakehouse llc
High PriorityActive

Butter Parsley Bagel Crisps, Item Number 18490, Net Weight: 10 lbs. Legacy Bakehouse, LLC, N8W22100 Johnson Dr., Waukesha, WI 53166.

Products were made with recalled California Dairies milk powder due to Salmonella.

Jun 3, 2026

Nicotine
High PriorityActive

Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88.

Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.

Jun 3, 2026

Pred mild
High PriorityActive

PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10.

Failed Stability Specifications

Jun 3, 2026

Wawa beverage company
High PriorityActive

Wawa Diet Iced Tea Lemon Pint (16oz),Plastic bottle

Undeclared Milk Allergen,

Jun 3, 2026