Prescription medicine
Chloramphenicol First approved as Chloromycetin
Chloramphenicol (Chloromycetin) is a prescription medicine with an FDA approval on record since 1951. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
- Boxed warning
Check it at the source: the chloramphenicol FDA label on DailyMed (effective October 10, 2024, Fresenius Kabi USA, LLC); the NDA 50156 record on Drugs@FDA; every chloramphenicol label on DailyMed.
Highlights of the record
FDA label of October 10, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia and granulocytopenia) are known to occur after the administration of chloramphenicol. In addition, there have been reports of aplastic anemia attributed to chloramphenicol which later terminated in leukemia. Blood dyscrasias have occurred after both short-term and prolonged therapy with this drug. Chloramphenicol must not be used when less potentially dangerous agents will be effective, as described in the INDICATIONS AND USAGE section. It must not be used in the treatment of trivial infections or where it is not indicated, as in colds, influenza, infections of the throat; or as a prophylactic agent to prevent bacterial infections. Precautions: It is essential that adequate blood studies be made during treatment with the drug. While blood studies may detect early peripheral blood changes, such as leukopenia, reticulocytopenia, or granulocytopenia, before they become irreversible, such studies cannot be relied on to detect bone marrow depression prior to development of aplastic anemia. To facilitate appropriate studies and observation during therapy, it is desirable that patients be hospitalized.
Used for
The label in openFDA carries no indications section.
Forms and strengths
- 1 g/10ml
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- June 1, 1951 Chloromycetin, Parkedale; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 11 first June 20, 1967; 0 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 1 under generic applications, 0 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)
- 0 since 2017 0 Class I among all firms' recalls; 3 more by firms not listed as its makers
- FAERS reports
- 28 through July 30, 2026
Is there a generic for chloramphenicol (Chloromycetin)?
The FDA approved the first generic chloramphenicol on June 20, 1967. 11 generic applications are approved; 0 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists chloramphenicol from 1 labeler under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1951 earliest approval on file
- 1967 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has chloramphenicol been recalled?
The FDA's Enforcement Report lists 3 recalls naming chloramphenicol since 2017: 0 Class I (the most serious), 3 Class II, 0 Class III; 0 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of chloramphenicol and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| November 16, 2017 | Class II | KRS Global Biotechnology, Inc not a listed maker | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the chloramphenicol label say about other medicines?
The chloramphenicol label names no other medicine on this site. The labels of 21 other medicines name chloramphenicol. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name chloramphenicol
Source: FDA drug label (Chloramphenicol Sodium Succinate), Fresenius Kabi USA, LLC, effective October 10, 2024 (SPL set aed29594-211d-49ef-813f-131975a8d0e3), via openFDA; the full label on DailyMed
What do FAERS reports show for chloramphenicol?
The FDA Adverse Event Reporting System holds 28 reports that list chloramphenicol 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 8 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Chloramphenicol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other