Zoledronic Acid recalls

The FDA has published 6 recalls involving Zoledronic Acid since 2014. The latest was reported on 5 Jun 2024. Most were for sterility. Dr. Reddy's Laboratories has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls6since 2014

Last 12 months0reported

Class I00% of total

Ongoing1latest 5 Jun 2024

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 3 50%Class III 3 50%

Why zoledronic acid is recalled

Companies

By year

2024117%
2020117%
2018233%
2016117%
2014117%

Ongoing zoledronic acid recalls

1 active

Reported	Class	Recall	Company	Reason	Where
5 Jun 2024Drug	CLASS II	Zoledronic Acid Injection 5mg/ Sterile Solution Single-Dose vials recalledZoledronic Acid	Dr. Reddy's Laboratories	Sterility	Nationwide

All zoledronic acid recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
5 Jun 2024Drug	CLASS II	Zoledronic Acid Injection 5mg/ Sterile Solution Single-Dose vials recalledZoledronic Acid	Dr. Reddy's Laboratories	Sterility	Nationwide
4 Mar 2020Drug	CLASS III	Zoledronic Acid Injection 5 mg/ 05 mg/mL), Solution recalled	Breckenridge Pharmaceutical	Sterility	Nationwide
3 Oct 2018Drug	CLASS III	Zoledronic Acid Injection, 5mg/ 05 mg/mL) vial recalledZoledronic Acid	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
3 Oct 2018Drug	CLASS III	Zoledronic Acid Injection, 5 mg/ 05 mg/mL) One Single-Dose recalledZoledronic Acid	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
6 Apr 2016Drug	CLASS II	Zoledronic Acid Injection, 5 mg/ 05 mg/mL) Single Use recalledZoledronic Acid	Dr. Reddy's Laboratories	Foreign Material	Nationwide
8 Oct 2014Drug	CLASS II	Zoledronic Acid Injection 5 mg per 05 mg/mL) single-use recalledZoledronic Acid	Sagent Pharmaceuticals	Sterility	Nationwide

Should you stop taking Zoledronic Acid?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.