Drug recall: Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 04
FDA enforcement event 81012 is a drug recall by an individual recalling firm (name withheld) of Princeton, NJ, initiated 12 Sep 2018 and classified Class III, with 2 product records.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 29% of the 367 drug enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 3 Mar 2020. Initiation: voluntary: firm initiated.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Individual recalling firm (name withheld), Princeton, NJ. FDA names an individual as the recalling firm; this site does not publish people's names.
Reason for recall
"Failed Impurities/Degradation Specifications: OOS for unknown impurities."
Distribution
"Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0103-2019 | 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 | 59,468 vials | Class III | Terminated | 3 Oct 2018 |
| D-0104-2019 | 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 | 10,530 vials | Class III | Terminated | 3 Oct 2018 |
Context
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed Impurities/Degradation Specifications: OOS for unknown impurities."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 3 Mar 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.