Dr. Reddy's Zoledronic Acid Recall: Sterility Risk
Dr. Reddy's recalls Zoledronic Acid Injection due to defective seals that may compromise sterility. Check lot BS523 and expiration date 10/2017.
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Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
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What happened, in plain English
Dr. Reddy's Laboratories is recalling Zoledronic Acid Injection because the metal silver ring on some vials was not attached tightly, leading to a lack of assurance of sterility. This defect affects 3,342 vials distributed nationwide. The record does not specify a remedy or action for consumers. Read more at govinfonow.com/recall/43133-dr-reddy-s-zoledronic-acid-recall-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/43133-dr-reddy-s-zoledronic-acid-recall-sterility-risk · Updated October 11, 2026 · FDA enforcement record: FDA #D-0784-2016
Cite this page
“Dr. Reddy's Zoledronic Acid Recall: Sterility Risk.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43133-dr-reddy-s-zoledronic-acid-recall-sterility-risk. Based on FDA recall #D-0784-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0784-2016%22&limit=1).
Why it’s dangerous
Defective seals where the metal silver ring was not attached tightly can allow contaminants to enter the vial, resulting in a lack of assurance of sterility. Using non-sterile injections can lead to serious infections.
Who’s affected
Patients prescribed Zoledronic Acid Injection who received vials from the specific lot and expiration date listed in the record.
How to tell if you have this one
Look for Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle manufactured by Gland Pharma Limited. Specifically check for NDC 55111-688-52, Lot BS523, and an expiration date of 10/2017.
- Brand
Dr. Reddy's Laboratories- Category
Drug
What to do — step by step
Check Your Medication
Verify if your Zoledronic Acid Injection matches NDC 55111-688-52, Lot BS523, and expires in 10/2017.
Contact Your Provider
Consult your healthcare provider or pharmacist regarding the recall and potential replacement options.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What is the NDC number for the recalled item?
The National Drug Code (NDC) is 55111-688-52.
How many vials are being recalled?
A total of 3,342 vials are included in this recall.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0784-2016 (March 3, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0784-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.