CLASS II Drug recall · Reported 6 Apr 2016 · FDA Enforcement Report
Zoledronic Acid Injection, 5 mg/ (0.05 mg/mL) Single Use recalled
Dr. Reddy's Laboratories is recalling Zoledronic Acid Injection, 5 mg/ (0.05 mg/mL) Single Use, distributed nationwide in the US. The recall was initiated on 3 Mar 2016 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0784-2016
- FDA event ID
- 73527
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Mar 2016
- FDA classified
- 28 Mar 2016
- Reported
- 6 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Injectable & IV Drugs
Timeline
| 3 Mar 2016 | Recall initiated by company | |
| 28 Mar 2016 | Classified by FDA | +25 days |
| 6 Apr 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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 was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
Which lots are affected?
Lot BS523, exp 10/2017
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 28 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Dr. Reddy's Laboratories
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalledSuccinylcholine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS I | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
Other Zoledronic Acid recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Zoledronic Acid Injection 5mg/ Sterile Solution Single-Dose vials recalled | Dr. Reddy's Laboratories | Sterility | Nationwide |
| Drug | CLASS III | Zoledronic Acid Injection 5 mg/ (0.05 mg/mL), Solution recalled | Breckenridge Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS III | Zoledronic Acid Injection, 5mg/ (0.05 mg/mL) vial recalled | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Zoledronic Acid Injection, 5 mg/ (0.05 mg/mL) One Single-Dose recalledZoledronic Acid | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |