Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported December 21, 2022
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 labeled as Omnipaque (iohexol) 300 mg I/mL, 2.4g Iodine/8 mL in a 10 mL syringe, Compounded with GE Healthcare product, Each mL contains (647 mg) of iohexol as 300 mg of organically bound iodine, 1.21 mg tromethamine, and 0.1 mg edetate calcium disodium, For Injection or oral use; Rx Only, BayCare Central Pharmacy, 7802 Telecom Parkway, Temple Terrace, FL 33637.
Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy recalled Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-coun… - a critical-severity action.
Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-coun… was recalled by BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy in December 21, 2022. Reason: Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg …. Check the official notice for the remedy. Verify recall #D-0086-2023 with the FDA Drug before acting.
The recall
BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy issued this critical-severity FDA Drug recall-Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg ….
- Critical
- severity level
- Class I
- classification
- December 21, 2022
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0086-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0086-2023) was formally reported on December 21, 2022, with the manufacturer initiating the action on December 1, 2022. It is classified under Critical severity (Class I), with a current status of Terminated. BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy is listed as the recalling firm, operating out of Temple Terrace, FL. Federal records list the affected scope as 250 syringes.
The documented reason for this recall is: Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL Distribution data in the federal record shows the product reached: BayCare Health System hospitals in FL. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
250 syringes
Related Recalls
6
5 from same agency
Product description
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 labeled as Omnipaque (iohexol) 300 mg I/mL, 2.4g Iodine/8 mL in a 10 mL syringe, Compounded with GE Healthcare product, Each mL contains (647 mg) of iohexol as 300 mg of organically bound iodine, 1.21 mg tromethamine, and 0.1 mg edetate calcium disodium, For Injection or oral use; Rx Only, BayCare Central Pharmacy, 7802 Telecom Parkway, Temple Terrace, FL 33637.
Reason for recall
Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-0086-2023 |
| Date reported | December 21, 2022 |
| Date initiated | December 1, 2022 |
| Recalling firm | BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy |
| Firm location | Temple Terrace, FL |
| Affected scope | 250 syringes |
| Distribution | BayCare Health System hospitals in FL |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0086-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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 labeled as Omnipaque (iohexol) 300 mg I/mL, 2.4g Iodine/8 mL in a 10 mL syringe, Compounded with GE Healthcare product, Each mL contains (647 mg) of iohexol as 300 mg of organically bound iodine, 1.21 mg tromethamine, and 0.1 mg edetate calcium disodium, For Injection or oral use; Rx Only, BayCare Central Pharmacy, 7802 Telecom Parkway, Temple Terrace, FL 33637.. Recalled by BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy. Units affected: 250 syringes.
Why was this product recalled? ▼
Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 21, 2022. Severity: Critical. Recall number: D-0086-2023.
Where was the recalled product distributed? ▼
Distribution: BayCare Health System hospitals in FL.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0086-2023) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
FDA Drug Low
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie c…
AbbVie Inc. · 2026-06-03
FDA Food Moderate
Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement, Net Wt. 8 FL Oz (237mL) Amber PET modern round 24-400 bot…
Llorens Pharmaceuticals International Division, Inc. · 2026-05-27
FDA Drug Moderate
Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by:…
Safecor Health, LLC · 2026-05-27
FDA Drug Moderate
fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3…
IntegraDose Compounding Services LLC · 2026-05-27
FDA Drug Moderate
Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, …
Lupin Pharmaceuticals Inc. · 2026-05-27
Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported December 21, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.