Prescription medicine
Glycine
Glycine is a prescription medicine with an FDA approval on record since 1976. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the glycine FDA label on DailyMed (effective April 1, 2021, B. Braun Medical Inc.); the NDA 17633 record on Drugs@FDA; every glycine label on DailyMed.
Highlights of the record
FDA label of April 1, 2021; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usage1.5% Glycine Irrigation USP is indicated as an irrigant during transurethral prostatic or bladder surgery.
Forms and strengths
- 1.5 g/100ml
Irrigant; solution.
On the market
- Earliest approval on file
- May 25, 1976 Glycine 1.5% In Plastic Container, Hospira; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 3 of which 0 under generic applications, 3 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 2013 0 Class I among all firms' recalls; latest July 30, 2025; 2 more by firms not listed as its makers
- FAERS reports
- 319 through July 30, 2026
What is glycine used for?
From the label: indications and usage1.5% Glycine Irrigation USP is indicated as an irrigant during transurethral prostatic or bladder surgery.
Source: FDA drug label (Glycine), B. Braun Medical Inc., effective April 1, 2021 (SPL set f4d83550-42de-44c7-b8d5-1d0debc6aec2), via openFDA; the full label on DailyMed
Is there a generic for glycine?
No generic glycine is approved (Drugs@FDA, October 8, 2026).
- 1976 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has glycine been recalled?
The FDA's Enforcement Report lists 3 recalls naming glycine since 2013: 0 Class I (the most serious), 3 Class II, 0 Class III; 1 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of glycine 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 |
|---|---|---|---|
| July 30, 2025 | Class II | GenoGenix LLC | Lack of Assurance of Sterility |
| January 15, 2020 | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical not a listed maker | Lack of Assurance of Sterility |
| July 26, 2013 | Class II | Beacon Hill Medical Pharmacy, P.C. not a listed maker | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the glycine label say about other medicines?
The glycine label names no other medicine on this site. The labels of 2 other medicines name glycine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name glycine
Source: FDA drug label (Glycine), B. Braun Medical Inc., effective April 1, 2021 (SPL set f4d83550-42de-44c7-b8d5-1d0debc6aec2), via openFDA; the full label on DailyMed
What do FAERS reports show for glycine?
The FDA Adverse Event Reporting System holds 319 reports that list glycine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 28 are coded as a death and 142 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?
- Glycine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other