Class II · Moderate risk
Zoledronic Acid Injection 5mg/100mL Sterile Solution
Lack of Assurance of Sterility: Leaking vials
Is Zoledronic Acid recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Zoledronic Acid (7 total). Check the affected lots below.
Most common reason: Impurity / degradation (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Zoledronic Acid. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Zoledronic Acid recalls on record
none so far in 2026; 7 on record, newest first
Class III · Low risk
Zoledronic Acid Injection 5 mg/100 mL
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
Class III · Low risk
Zoledronic Acid Injection
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Class III · Low risk
Zoledronic Acid Injection
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Class II · Moderate risk
Zoledronic Acid Injection
Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
Class II · Moderate risk
Zoledronic Acid active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Zoledronic Acid Injection 5 mg per 100 mL
Lack of Assurance of Sterility; leaking of premix bags
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