Zoledronic Acid

Zoledronic Acid recalls: 5 FDA reports

Recalls involving Zoledronic Acid. What was wrong with each batch, and how the FDA graded the risk.

5Reports
0Class I
1Ongoing
2024-06-05Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReports
Class II3
Class III2

By year reported

YearReports
20141
20161
20182
20241
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy

D-0510-2024  ·  Class II  ·  reported 2024-06-05  ·  Ongoing

Why it was recalled
Lack of Assurance of Sterility: Leaking vials
Product
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
Where it went
Nationwide within the United States
How much
13,880 vials

Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bottle, Rx Only. NOVAPLUS Mfd By: Gl

D-0104-2019  ·  Class III  ·  reported 2018-10-03  ·  Terminated

Why it was recalled
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Product
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 India. N+ and NOVAPLUS are registered trademarks of Vizient, Inc. NDC 43598-331-11
Where it went
Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States.
How much
10,530 vials

Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pall

D-0103-2019  ·  Class III  ·  reported 2018-10-03  ·  Terminated

Why it was recalled
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Product
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
Where it went
Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States.
How much
59,468 vials

Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma

D-0784-2016  ·  Class II  ·  reported 2016-04-06  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
Product
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
Where it went
Nationwide
How much
3,342 vials

Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx

D-1615-2014  ·  Class II  ·  reported 2014-10-08  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility; leaking of premix bags
Product
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
Where it went
Nationwide
How much
10,622 bags
Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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