Quick answers
- What is Zoledronic acid used for?
- The FDA-approved label (Reclast, Sandoz Inc, February 3, 2026) says: “Reclast is a bisphosphonate indicated for: • Treatment and prevention of postmenopausal osteoporosis ( 1.1, 1.2 ) • Treatment to increase bone mass in men with osteoporosis • Treatment and prevention of glucocorticoid-induced osteoporosis • Treatment of Paget’s disease of bone in men and women Limitations of Use Optimal duration of use has not been determined. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Zoledronic acid have a boxed warning?
- No. None of the 31 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Zoledronic acid?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Zoledronic acid been recalled?
- FDA enforcement reports list 5 recalls of products of this medicine; the newest started May 23, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Zoledronic acid?
- 20 companies list prescription products of Zoledronic acid in the FDA NDC Directory, including Gland Pharma Limited, Dr. Reddy's Laboratories Inc. and Sagent Pharmaceuticals.
What Zoledronic acid is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Reclast is a bisphosphonate indicated for: • Treatment and prevention of postmenopausal osteoporosis ( 1.1, 1.2 ) • Treatment to increase bone mass in men with osteoporosis • Treatment and prevention of glucocorticoid-induced osteoporosis • Treatment of Paget’s disease of bone in men and women Limitations of Use Optimal duration of use has not been determined. …
— FDA label: Reclast, Sandoz Inc, effective February 3, 2026. Read the full label on DailyMed →
The FDA has 31 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.
0 of 31 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution, concentrate · Injection, solution · Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 34 in the FDA NDC Directory |
| Brand names | Reclast |
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 |
|---|---|---|
| zoledronic acid 5 mg/100 mL injection, solution | Generic | $0.4657 per mL |
NADAC list of November 4, 2026; these prices took effect on 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.
- Gland Pharma Limited6 products
- Dr. Reddy's Laboratories Inc.4 products
- Sagent Pharmaceuticals3 products
- Mylan Institutional LLC3 products
- BluePoint Laboratories2 products
- BPI Labs LLC2 products
- Fresenius Kabi USA, LLC2 products
- NorthStar Rx LLC1 product
- Accord Healthcare Inc.1 product
- Fosun Pharma USA Inc.1 product
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 product
- AuroMedics Pharma LLC1 product
- Eugia US LLC1 product
- Meitheal Pharmaceuticals Inc.1 product
- Westminster Pharmaceuticals, LLC1 product
- Dr. Reddy's Laboratories Limited1 product
- Dr.Reddy's Laboratories Ltd.1 product
- Hikma Pharmaceuticals USA Inc.1 product
- Avenacy Inc.1 product
- Sandoz Inc1 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 |
|---|---|---|---|
| NDA021817 RECLAST | Sandoz | April 16, 2007 | 20, latest February 3, 2026 2026: Labeling · 2020: Labeling · 2017: Labeling |
| NDA203231 ZOLEDRONIC ACID | Inforlife | August 2, 2013 | 15, latest April 5, 2022 2022: Labeling · 2020: Labeling · 2020: Labeling |
Generic approvals (20)
- ANDA091186DR Reddys Labs Ltd · March 4, 2013
- ANDA202650Mylan Labs Ltd · March 4, 2013
- ANDA201783Avet Lifesciences · March 12, 2013
- ANDA091363DR Reddys Labs Ltd · March 29, 2013
- ANDA202182Hikma Farmaceutica · June 3, 2013
- ANDA202930Gland · August 5, 2013
- ANDA202828Inforlife · September 23, 2013
- ANDA202923Usv · September 4, 2014
- ANDA204217Gland · August 18, 2016
- ANDA207751Eugia Pharma · September 26, 2016
- ANDA205279Accord Hlthcare · November 28, 2016
- ANDA203841Mylan Labs Ltd · February 14, 2017
- ANDA205254Mylan Labs Ltd · October 27, 2017
- ANDA209125Eugia Pharma · December 8, 2017
- ANDA207341Bpi Labs · December 29, 2017
- ANDA205749Gland · June 29, 2018
- ANDA204344DR Reddys · November 19, 2018
- ANDA209578Gland · August 8, 2019
- ANDA213371Meitheal · June 5, 2023
- ANDA219984Gland · February 5, 2026
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.
-
May 23, 2024 · Class II · Ongoing · D-0510-2024
Lack of Assurance of Sterility: Leaking vials
Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-688-52 — Dr. Reddy's Laboratories, Inc.
-
September 12, 2018 · Class III · Terminated · D-0104-2019
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bottle, Rx Only. NOVAPLUS Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 — Dr. Reddy's Laboratories, Inc.
-
September 12, 2018 · Class III · Terminated · D-0103-2019
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India. NDC 55111-688-52 — Dr. Reddy's Laboratories, Inc.
-
March 3, 2016 · Class II · Terminated · D-0784-2016
Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D.P. Pally - 500 043 INDIA NDC 55111-688-52 — Dr. Reddy's Laboratories, Inc.
-
March 4, 2014 · Class II · Terminated · D-1615-2014
Lack of Assurance of Sterility; leaking of premix bags
Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Sterile, For Intravenous Infusion, Mfd. for Sagent Pharmaceuticals Schaumburg, IL ---- NDC 25021-830-82 — Sagent Pharmaceuticals 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) | 351114, 705824, 705875, 1114085 |
|---|---|
| SPL set ID of the quoted label | 5a9b3737-9ce6-4a89-b76e-6aab79eba9cf |
| FDA labels (SPL) | 31 |
| FDA applications | NDA021817, NDA203231, 20 ANDA |
| Active ingredients (FDA) | ZOLEDRONIC ACID |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Reclast, Sandoz Inc, effective February 3, 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 →