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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Omnipaque Iohexol Contrast Syringes Recalled for Incorrect Strength

Agency Publication Date: December 13, 2022
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Summary

BayCare Central Pharmacy has voluntarily recalled 250 syringes of Iohexol (300 mg Iodine/mL), an injectable contrast agent used in medical imaging. The syringes were mislabeled as containing 300 mg of iodine per mL when they actually contained a higher strength of 350 mg per mL. This recall affects 8 mL syringes packaged in 5-count bags labeled under the brand name Omnipaque. No injuries or adverse incidents have been reported to date.

Risk

Using a higher concentration of iodine contrast than intended can lead to incorrect dosing during medical procedures, which may increase the risk of adverse reactions or complications for patients.

What You Should Do

  1. This recall affects 8 mL syringes of Iohexol (300 mg Iodine/mL) packaged in 5-count bags labeled as Omnipaque (iohexol) 300 mg I/mL.
  2. Identify affected products by checking for lot number IOHE2.420221128 with an expiration date of 12/7/2022, or lot number IOHE2.
  3. Stop using the recalled syringes immediately and remove them from active inventory.
  4. Contact BayCare Integrated Service Center/BayCare Central Pharmacy or your distributor to arrange for the return of the recalled product.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information or to report a concern.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Iohexol (300 mg Iodine/mL) Contrast Syringesby Omnipaque
Variants: 300 mg Iodine/mL, 8 mL in 10 mL syringe, 5-count syringes per bag
Lot Numbers:
IOHE2.420221128 (Exp. 12/7/2022)
IOHE2

Compounded with GE Healthcare product; each mL contains 647 mg of iohexol; syringes mislabeled as 300 mg/mL contained 350 mg/mL.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91283
Status: Resolved
Manufacturer: BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
Sold By: BayCare Health System hospitals
Manufactured In: United States
Units Affected: 250 syringes
Distributed To: Florida
Agency Last Updated: December 22, 2022

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.