Prescription medicine

Mebrofenin Brand names: Choletec

Mebrofenin (Choletec) is a prescription medicine. FDA's NDC Directory lists it from 1 generic labeler.

Generic listed

Check it at the source: the mebrofenin FDA label on DailyMed (effective November 29, 2025); every mebrofenin label on DailyMed.

Highlights of the record

FDA label of November 29, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
Technetium Tc 99m Mebrofenin is indicated as a hepatobiliary imaging agent.

Forms and strengths

45 mg
45 mg/10ml

Injection (powder) (lyophilized) for solution.

On the market

Generic approvals: No generic approved
Labelers listed (NDC): 2 of which 1 under generic applications, 1 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): 2 since 2012 0 Class I among all firms' recalls; latest April 10, 2018
FAERS reports: 94 through July 30, 2026

What is mebrofenin used for?

From the label: indications and usage
Technetium Tc 99m Mebrofenin is indicated as a hepatobiliary imaging agent.

Source: FDA drug label (Choletec), Bracco Diagnostics Inc, effective November 29, 2025 (SPL set fd085485-998d-42a3-879a-b2d96cb8aed7), via openFDA; the full label on DailyMed

Is there a generic for mebrofenin (Choletec)?

No generic mebrofenin is approved (Drugs@FDA, October 8, 2026).

FDA's NDC Directory lists mebrofenin from 1 labeler under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

Has mebrofenin been recalled?

The FDA's Enforcement Report lists 2 recalls naming mebrofenin since 2012: 0 Class I (the most serious), 1 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.

Started	Class	Company	Reason
April 10, 2018	Class II	Pharmalucence, Inc.	Failed Stability Specifications
August 14, 2012	Class III	Bracco Diagnostic Inc	Presence of Particulate Matter; potential for charcoal particulates

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What do FAERS reports show for mebrofenin?

The FDA Adverse Event Reporting System holds 94 reports that list mebrofenin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4 are coded as a death and 12 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

Drug Effect Decreased34
Multiple Use Of Single-Use Product29
Nausea (named in the label)11
Hypersensitivity6
Vomiting6
Drug Ineffective (a use or a product term, not a reaction)5
Asthenia4
Chills (named in the label)4

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Mebrofenin side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other