Recall of GE Healthcare's Omnipaque Injection Due to Particulate Matter
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GE Healthcare is voluntarily recalling 306,810 vials of Omnipaque injection across multiple lots due to the presence of particulate matter, affecting products distributed nationwide in the U.S.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 22, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
GE Healthcare is recalling certain lots of Omnipaque injection because of the presence of particulate matter, which was identified as the reason for this voluntary recall initiated by the firm.
Which Products Are Affected
The affected products are GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL, with the following lot numbers and expiration dates: Lot# 17333197 (Exp. December 10, 2028), Lot# 17333198 (Exp. November 17, 2028), Lot# 17396945 (Exp. December 18, 2028), Lot# 17396948 (Exp. December 22, 2028), Lot# 17396953 (Exp. January 11, 2029), Lot# 17396956 (Exp. January 9, 2029), Lot# 17423503 (Exp. January 1, 2029), Lot# 17423525 (Exp. January 3, 2029), Lot# 17426429 (Exp. January 1, 2029), Lot# 17426440 (Exp. January 4, 2029), and Lot# 17431310 (Exp. January 11, 2029). A total of 306,810 vials are affected, distributed in the U.S. nationwide. The product is a human prescription drug with NDC codes such as 0407-1414-91.
What You Should Do
Consumers and healthcare providers in possession of the affected lots should contact the recalling firm, GE Healthcare Ireland Limited, for instructions on returns or further actions related to this recall.
Why This Matters
This recall involves a prescription drug used for medical imaging, and the presence of particulate matter could pose potential risks to patient safety, highlighting the importance of quality control in pharmaceutical products.
Source
FDA Recall Number: D-0448-2026. For more information, refer to the FDA website at https://www.fda.gov/.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,555 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 22, 2026.
Frequently Asked Questions
Common questions about this FDA recall.