Quick answers
- What is Vancomycin used for?
- The FDA-approved label (Tyzavan, Hikma Pharmaceuticals USA Inc., August 19, 2026) says: “TYZAVAN is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients (1 month and older) for whom appropriate dosing with this formulation can be achieved …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Vancomycin have a boxed warning?
- The label we quote has no boxed warning, but 2 of 74 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Vancomycin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Vancomycin been recalled?
- FDA enforcement reports list 9 recalls of products of this medicine; the newest started August 6, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Vancomycin?
- 33 companies list prescription products of Vancomycin in the FDA NDC Directory, including Hikma Pharmaceuticals USA Inc., Fresenius Kabi USA, LLC and Mylan Institutional LLC.
What Vancomycin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
TYZAVAN is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients (1 month and older) for whom appropriate dosing with this formulation can be achieved …
— FDA label: Tyzavan, Hikma Pharmaceuticals USA Inc., effective August 19, 2026. Read the full label on DailyMed →
The FDA has 74 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
2 of 74 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution · Injection, solution · Capsule · Injection, powder, for solution · Powder, for solution · Solution |
|---|---|
| Route | Intravenous · Oral · Intravitreal |
| Prescription products | 143 in the FDA NDC Directory |
| Brand names | Tyzavan, Vancocin |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| vancomycin hydrochloride 125 mg capsule | Generic | $1.21 per capsule |
| vancomycin hydrochloride 250 mg capsule | Generic | $2.25 per capsule |
| vancomycin hydrochloride 250 mg/5 mL powder, for solution | Generic | $0.6540–$2.91 per mL 3 packages, lowest to highest |
| vancomycin hydrochloride 250 mg/5 mL solution | Generic | $0.8007–$2.91 per mL 2 packages, lowest to highest |
| vancomycin hydrochloride 500 mg injection, powder, lyophilized, for solution | Generic | $2.31 per unit |
| vancomycin hydrochloride 500 mg/10 mL injection, powder, lyophilized, for solution | Generic | $2.31 per unit |
NADAC list of November 4, 2026; these prices took effect between December 17, 2025 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Hikma Pharmaceuticals USA Inc.21 products
- Fresenius Kabi USA, LLC11 products
- Mylan Institutional LLC9 products
- Xellia Pharmaceuticals USA LLC9 products
- Bryant Ranch Prepack8 products
- Baxter Healthcare Corporation8 products
- Hospira, Inc.8 products
- Sagent Pharmaceuticals7 products
- Gland Pharma Limited7 products
- Glenmark Pharmaceuticals Inc., USA7 products
- Eugia US LLC6 products
- ANI Pharmaceuticals, Inc.5 products
- Meitheal Pharmaceuticals Inc.5 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.4 products
- Fresenius Kabi, LLC4 products
- Slate Run Pharmaceuticals, LLC4 products
- Avenacy, LLC3 products
- Steriscience Specialties Private Limited3 products
- Civica, Inc.3 products
- Eurofarma, Inc.2 products
- Redpharm Drug2 products
- Camber Pharmaceuticals, Inc.2 products
- Cameron Pharmaceuticals2 products
- Plano Pharmaceuticals Inc.2 products
- PAI Holdings, LLC dba PAI Pharma2 products
- BluePoint Laboratories2 products
- XGen Pharmaceuticals DJB, Inc.2 products
- Strides Pharma Science Limited2 products
- Zhejiang Novus Pharma Co., Ltd.1 product
- Henry Schein, Inc.1 product
- Advanced Rx of Tennessee, LLC1 product
- Amneal Pharmaceuticals NY LLC1 product
- Samson Medical Technologies LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA050606 VANCOCIN HYDROCHLORIDE | Ani Pharms | April 15, 1986 | 21, latest December 22, 2021 2021: Labeling · 2021: Labeling · 2020: Labeling |
| NDA050671 VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER | Baxter Hlthcare | April 29, 1993 | 18, latest June 9, 2026 2026: Labeling · 2025: Labeling · 2024: Labeling |
| NDA209481 VANCOMYCIN HYDROCHLORIDE | Mylan Labs Ltd | July 10, 2018 | 4, latest June 26, 2024 2024: Efficacy · 2022: Labeling · 2021: Labeling |
| NDA210274 VANCOMYCIN HYDROCHLORIDE | Zhejiang Novus Pharm | January 20, 2023 | 2, latest May 29, 2025 2025: Labeling · 2024: Manufacturing (CMC) |
| NDA211962 TYZAVAN | Hikma | February 15, 2019 | 6, latest August 18, 2026 2026: Labeling · 2025: Efficacy · 2025: Labeling |
Generic approvals (35)
- ANDA061667Ani Pharms · July 13, 1983
- ANDA062663Fresenius Kabi USA · March 17, 1987
- ANDA062911Hospira · August 4, 1988
- ANDA062912Hospira · August 4, 1988
- ANDA063076Hospira · December 21, 1990
- ANDA065401Eurofarma · June 30, 2008
- ANDA065397Mylan Labs Ltd · December 30, 2008
- ANDA065432Mylan Labs Ltd · December 30, 2008
- ANDA090250Plano Pharms · April 27, 2010
- ANDA091554Mylan Labs Ltd · September 19, 2011
- ANDA065478Pai Holdings · April 9, 2012
- ANDA065490Strides Pharma · April 9, 2012
- ANDA200837Sagent Pharms · August 10, 2012
- ANDA201048Plano Pharms · August 10, 2012
- ANDA204107Hikma · December 28, 2015
- ANDA204125Xellia Pharms Aps · December 28, 2015
- ANDA091532Samson Medcl · January 6, 2016
- ANDA205694Gland · January 21, 2016
- ANDA205779Eugia Pharma · March 29, 2016
- ANDA205780Eugia Pharma · March 31, 2016
- ANDA206616Hikma Pharms · October 3, 2018
- ANDA204360Hikma · October 15, 2018
- ANDA210729Orient Pharma Co Ltd · April 29, 2019
- ANDA212332Hainan Poly · June 12, 2019
- ANDA203300Hikma · August 11, 2020
- ANDA215821Hainan Poly · November 18, 2021
- ANDA216591Aspiro · July 6, 2022
- ANDA215196Meitheal · July 27, 2022
- ANDA215197Meitheal · July 28, 2022
- ANDA215195Meitheal · September 15, 2022
- ANDA215338Amneal · June 23, 2023
- ANDA217489Hikma · June 29, 2023
- ANDA217401Eugia Pharma · August 4, 2023
- ANDA218140Gland · March 21, 2025
- ANDA215324Steriscience · October 2, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
August 6, 2026 · Class II · Ongoing · D-0805-2026
CGMP Deviations
Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3552-48. — Baxter Healthcare Corporation
-
August 6, 2026 · Class II · Ongoing · D-0820-2026
CGMP Deviations
Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3583-01. — Baxter Healthcare Corporation
-
March 21, 2024 · Class I · Terminated · D-0442-2024
Superpotent Drug: Due to overfilling of drug powder
Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Distributed by: Amneal P — Amneal Pharmaceuticals of New York, LLC
-
December 22, 2022 · Class I · Terminated · D-0184-2023
Presence of Particulate Matter: Glass particulate matter detected in injectable.
Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials per carton, Rx only, Distributed by: Hospira, Inc., Lake Forest, IL 60045. NDC Vial 0409-3515-11; NDC Carton 040 — Pfizer Inc.
-
November 25, 2019 · Class II · Terminated · D-0574-2020
Discoloration: Product complaints of discoloration after reconstitution of vials.
Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in India for: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-204-20. — AuroMedics Pharma LLC
-
August 30, 2017 · Class I · Terminated · D-0123-2018
Presence of Particulate Matter: glass particulate found in vial
Vancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only. Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-6531-02 — Pfizer Inc.
-
November 7, 2014 · Class III · Terminated · D-0254-2015
Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product.
Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g in 25 ml fliptop vial, 10-count tray, Rx only, Manufactured by Hospira, Inc. Lake Forest, IL 60045, NDC 0409-6533-01. — Hospira Inc.
-
October 6, 2014 · Class II · Terminated · D-0390-2015
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Vancomycin Hydrochloride for Injection, USP, 1 g Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-6533-01. — Hospira Inc.
-
October 6, 2014 · Class II · Terminated · D-0387-2015
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Vancomycin Hydrochloride for Injection, USP, 500 mg Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4332-01. — Hospira Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 201848, 201849, 239209, 313570, 313571, 313572, 1807508, 1807510, 1807511, 1807513 … (+10) |
|---|---|
| SPL set ID of the quoted label | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 |
| FDA labels (SPL) | 74 |
| FDA applications | NDA050606, NDA050671, NDA209481, NDA210274, NDA211962, 35 ANDA |
| Active ingredients (FDA) | VANCOMYCIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tyzavan, Hikma Pharmaceuticals USA Inc., effective August 19, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →