Omnipaque Injection, Solution
FDA Recall NDC 0407-1413
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Omnipaque (NDC 0407-1413). A significant event, classified as Class II, was initiated on Mar 24, 2026 by Ge Healthcare Inc.. The reported reason for this action was: "Presence of particulate matter"
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 particulate matter
Mar 24, 2026
Apr 15, 2026
306,810 vials
Recall Profile & Regulatory Data
Event ID
98656
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
GE Healthcare Ireland Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide.
Product Description
GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.
Batch or Lot Expiration Information
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
Lot# 17431310; Exp. January 11, 2029
Affected Packages Involved in this Recall
0407-1401-52Product
0407-1411-10Product
0407-1411-20Product
0407-1412-10Product
0407-1412-20Product
0407-1412-50Product
0407-1412-29Product
0407-1412-30Product
0407-1412-60Product
0407-1412-33Product
0407-1412-27Product
0407-1412-49Product
0407-1412-34Product
0407-1412-28Product
0407-1412-35Product
0407-1413-11Product
0407-1413-10Product
0407-1413-59Product
0407-1413-30Product
0407-1413-50Product
0407-1413-51Product
0407-1413-61Product
0407-1413-95Product
0407-1413-98Product
0407-1413-62Product
0407-1413-99Product
0407-1413-60Product
0407-1413-63Product
0407-1413-91Product
0407-1413-53Product
0407-1413-90Product
0407-1413-65Product
0407-1413-92Product
0407-1413-66Product
0407-1413-93Product
0407-1413-96Product
0407-1413-69Product
0407-1414-21Product
0407-1414-50Product
0407-1414-51Product
0407-1414-52Product
0407-1414-89Product
0407-1414-20Product
0407-1414-90Product
0407-1414-22Product
0407-1414-53Product
0407-1414-60Product
0407-1414-91Product
0407-1414-76Product
0407-1414-03Product
0407-1414-23Product
0407-1414-93Product
0407-1414-04Product
0407-1414-94Product
0407-1414-24Product
0407-1414-80Product
0407-1414-95Product
0407-1415-09Product
0407-1416-12Product
Class II Ongoing
Presence of particulate matter
Mar 24, 2026
Apr 15, 2026
866,570 vials
Recall Profile & Regulatory Data
Event ID
98656
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
GE Healthcare Ireland Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide.
Product Description
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.
Batch or Lot Expiration Information
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
Affected Packages Involved in this Recall
0407-1401-52Product
0407-1411-10Product
0407-1411-20Product
0407-1412-10Product
0407-1412-20Product
0407-1412-50Product
0407-1412-29Product
0407-1412-30Product
0407-1412-60Product
0407-1412-33Product
0407-1412-27Product
0407-1412-49Product
0407-1412-34Product
0407-1412-28Product
0407-1412-35Product
0407-1413-11Product
0407-1413-10Product
0407-1413-59Product
0407-1413-30Product
0407-1413-50Product
0407-1413-51Product
0407-1413-61Product
0407-1413-95Product
0407-1413-98Product
0407-1413-62Product
0407-1413-99Product
0407-1413-60Product
0407-1413-63Product
0407-1413-91Product
0407-1413-53Product
0407-1413-90Product
0407-1413-65Product
0407-1413-92Product
0407-1413-66Product
0407-1413-93Product
0407-1413-96Product
0407-1413-69Product
0407-1414-21Product
0407-1414-50Product
0407-1414-51Product
0407-1414-52Product
0407-1414-89Product
0407-1414-20Product
0407-1414-90Product
0407-1414-22Product
0407-1414-53Product
0407-1414-60Product
0407-1414-91Product
0407-1414-76Product
0407-1414-03Product
0407-1414-23Product
0407-1414-93Product
0407-1414-04Product
0407-1414-94Product
0407-1414-24Product
0407-1414-80Product
0407-1414-95Product
0407-1415-09Product
0407-1416-12Product
Class II Terminated
Defective Container: vial defect was identified that could potentially impact the container closure and result in a lack of sterility assurance and/or the potential for glass particles.
Oct 29, 2018
Dec 26, 2018
1092 cartons
Recall Profile & Regulatory Data
Event ID
81691
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
GE Healthcare Inc. Life Sciences
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
TN
Termination Date
Oct 30, 2023
Product Description
Omnipaque (iohexol) Injection, 180mgI/mL, 20 mL Single-Dose Vial, packaged in 10 x 20 mL Vials per carton, Rx only, Distributed by GE Healthcare Inc., Marlborough, MA 01752 U.S.A.; Manufactured by GE Healthcare AS, Oslo, Norway; NDC 0407-1411-20.
Batch or Lot Expiration Information
Lot# : 14301544, Exp 21Sep21
Affected Packages Involved in this Recall
0407-1401-52Product
0407-1411-10Product
0407-1411-20Product
0407-1412-10Product
0407-1412-20Product
0407-1412-50Product
0407-1412-29Product
0407-1412-30Product
0407-1412-60Product
0407-1412-33Product
0407-1412-27Product
0407-1412-49Product
0407-1412-34Product
0407-1412-28Product
0407-1412-35Product
0407-1413-11Product
0407-1413-10Product
0407-1413-59Product
0407-1413-30Product
0407-1413-50Product
0407-1413-51Product
0407-1413-61Product
0407-1413-95Product
0407-1413-98Product
0407-1413-62Product
0407-1413-99Product
0407-1413-60Product
0407-1413-63Product
0407-1413-91Product
0407-1413-53Product
0407-1413-90Product
0407-1413-65Product
0407-1413-92Product
0407-1413-66Product
0407-1413-93Product
0407-1413-96Product
0407-1413-69Product
0407-1414-21Product
0407-1414-50Product
0407-1414-51Product
0407-1414-52Product
0407-1414-89Product
0407-1414-20Product
0407-1414-90Product
0407-1414-22Product
0407-1414-53Product
0407-1414-60Product
0407-1414-91Product
0407-1414-76Product
0407-1414-03Product
0407-1414-23Product
0407-1414-93Product
0407-1414-04Product
0407-1414-94Product
0407-1414-24Product
0407-1414-80Product
0407-1414-95Product
0407-1415-09Product
0407-1416-12Product
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.
