Prescription medicine
Thrombin topical recombinant Brand names: Recothrom
Thrombin topical recombinant (Recothrom) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the thrombin topical recombinant FDA label on DailyMed (effective June 9, 2025); every thrombin topical recombinant label on DailyMed.
Highlights of the record
FDA label of June 9, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageRECOTHROM Thrombin topical (Recombinant), is a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age.
Forms and strengths
Kit.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 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)
- 1 since 2022 0 Class I among all firms' recalls; latest April 13, 2022
- FAERS reports
- 67 through July 30, 2026
What is thrombin topical recombinant used for?
From the label: indications and usageRECOTHROM Thrombin topical (Recombinant), is a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age. RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP. […]
Source: FDA drug label (RECOTHROM), Baxter Healthcare Corporation, effective June 9, 2025 (SPL set 54885644-e51e-4263-aadb-366abaeb56a3), via openFDA; the full label on DailyMed
Is there a generic for thrombin topical recombinant (Recothrom)?
No generic thrombin topical recombinant is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has thrombin topical recombinant been recalled?
The FDA's Enforcement Report lists 1 recall naming thrombin topical recombinant since 2022: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for thrombin topical recombinant?
The FDA Adverse Event Reporting System holds 67 reports that list thrombin topical recombinant among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Thrombin topical recombinant side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other