Prescription medicine
Carbachol Brand names: Miostat
Carbachol (Miostat) is a prescription medicine with an FDA approval on record since 1972. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the carbachol FDA label on DailyMed (effective February 10, 2023, Alcon Laboratories, Inc.); the NDA 16968 record on Drugs@FDA; every carbachol label on DailyMed.
Highlights of the record
FDA label of February 10, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageIntraocular use for obtaining miosis during surgery.
Forms and strengths
- 0.1 mg/ml
Solution.
On the market
- Earliest approval on file
- September 28, 1972 Miostat, Alcon; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first April 28, 1995; 0 with a marketed status in Drugs@FDA
- 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
- 162 through July 30, 2026
What is carbachol used for?
From the label: indications and usageIntraocular use for obtaining miosis during surgery. In addition, MIOSTAT* (carbachol intraocular solution, USP) 0.01% reduces the intensity of IOP elevation in the first 24 hours after cataract surgery.
FDA pharmacologic class: Cholinergic Receptor Agonist.
Source: FDA drug label (MIOSTAT), Alcon Laboratories, Inc., effective February 10, 2023 (SPL set f28d7a56-e079-4a8b-ad81-9a97c780de67), via openFDA; the full label on DailyMed
Is there a generic for carbachol (Miostat)?
The FDA approved the first generic carbachol on April 28, 1995. 1 generic application is approved; 0 of it carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
- 1972 earliest approval on file
- 1995 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has carbachol been recalled?
The FDA's Enforcement Report lists 1 recall naming carbachol 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 does the carbachol label say about other medicines?
The carbachol label names no other medicine on this site. The labels of 3 other medicines name carbachol. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name carbachol
Source: FDA drug label (MIOSTAT), Alcon Laboratories, Inc., effective February 10, 2023 (SPL set f28d7a56-e079-4a8b-ad81-9a97c780de67), via openFDA; the full label on DailyMed
What do FAERS reports show for carbachol?
The FDA Adverse Event Reporting System holds 162 reports that list carbachol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 49 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?
- Other cholinergic receptor agonists
- the pharmacologic class, with prices and generics
- Carbachol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other