Prescription medicine
Talc Brand names: Steritalc; first approved as Sclerosol
Talc (Sclerosol) is a prescription medicine with an FDA approval on record since 1997. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the talc FDA label on DailyMed (effective June 25, 2025); the NDA 20587 record on Drugs@FDA; every talc label on DailyMed.
Highlights of the record
FDA label of June 25, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageINDICATIONS AND USAGE 1.INDICATIONS AND USAGE 1.1 Malignant Pleural Effusion STERITALC is indicated to decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion.
Forms and strengths
- 2 g/50ml
- 3 g/10ml
- 4 g/50ml
Powder.
On the market
- Earliest approval on file
- December 24, 1997 Sclerosol, Sciarra Labs; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- 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)
- 0 since 2022 0 Class I among all firms' recalls; 1 more by firms not listed as its makers
- FAERS reports
- 420 through July 30, 2026
What is talc used for?
From the label: indications and usageINDICATIONS AND USAGE 1.INDICATIONS AND USAGE 1.1 Malignant Pleural Effusion STERITALC is indicated to decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion. 1.2 Pneumothorax STERITALC is indicated in adults to decrease the recurrence of pneumothorax. ___________ INDICATIONS AND USAGE__ __________ STERITALC® is a sclerosing agent indicated: To decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion. (1.1) In adults to decrease the recurrence of pneumothorax.
Source: FDA drug label (Steritalc 2g), Novatech SA, effective June 25, 2025 (SPL set c94e51d9-beef-4b06-e053-2a95a90a754a), via openFDA; the full label on DailyMed
Is there a generic for talc (Sclerosol)?
No generic talc is approved (Drugs@FDA, October 8, 2026).
- 1997 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has talc been recalled?
The FDA's Enforcement Report lists 1 recall naming talc since 2022: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of talc and that holds 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 |
|---|---|---|---|
| October 7, 2022 | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder not a listed maker | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for talc?
The FDA Adverse Event Reporting System holds 420 reports that list talc among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 108 are coded as a death and 45 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?
- Talc side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other