Lower riskDrug recall · FDA · Published December 1, 2022
BayCare Central Pharmacy Iohexol Syringes Mislabeled - Risk of Incorrect Dose
BayCare Central Pharmacy recalls 5-count iohexol syringes mislabeled as 300 mg iodine/mL when they contain 350 mg. This labeling error could lead to incorrect dosing during medical procedures. Affected products were sold with specific lot numbers and expiration dates.
“BayCare Central Pharmacy Iohexol Syringes Mislabeled - Risk of Incorrect Dose.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34209-baycare-central-pharmacy-iohexol-syringes-mislabeled-risk-of-incorrect-dose. Based on FDA recall #D-0086-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0086-2023%22&limit=1).
The FDA announced on 2022-12-01 that BayCare Central Pharmacy recalled Iohexol syringes due to a labeling error where the product contained 350 mg iodine/mL instead of the declared 300 mg. The recall affects 250 units distributed to BayCare Health System hospitals in Florida.
How to tell if you have it
Brand: BayCare Central Pharmacy
Product: Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-count syringes packaged in a bag
Lot: IOHE2.420221128
Expiration Date: 12/7/2022
Quantity: 250 syringes
The hazard
The syringes were mislabeled as containing 300 mg iodine/mL but actually contained product with 350 mg iodine/mL. This constitutes a labeling error regarding the declared strength of the drug.
Context
GovInfoNow's records show BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy has issued two other recalls since 2021-07-30. On 2022-02-14, the pharmacy recalled Norepinephrine IV Solution due to a subpotent drug hazard, and on 2021-07-30, it recalled sterile IV syringes due to a lack of sterility assurance. Other recent recalls of similar products include Otsuka ICU Medical Potassium Chloride Inj. 20mEq Label Error Recall (2025-10-29), ICU Medical Recalls Potassium Chloride Injection Due to Label Error (2025-10-29), and Safecor Atomoxetine Capsules 10mg Mislabeled as 25mg - Label Error (2026-04-30).
How to tell if you have this one
Look for syringes labeled as Omnipaque (iohexol) 300 mg I/mL, 2.4g Iodine/8 mL in a 10 mL syringe. The lot number IOHE2.420221128 and expiration date 12/7/2022 are associated with this recall.
Brand
BayCare Central Pharmacy
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Label
Verify the label states 300 mg iodine/mL, but the actual product contains 350 mg iodine/mL.
Where it went and when
Where it was distributed
Distributed in Florida.
Listed by the agency
Not listed
FDA distribution: “BayCare Health System hospitals in FL” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
1Firm started the recall
2Published in FDA’s Enforcement Report
3FDA classified it Class I
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0086-2023 (December 1, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0086-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.