Dr. Reddy's Laboratories, Inc. recalls Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bottle, Rx Only. NOVAPLUS Mfd By: Gland
Dr. Reddy's recalls Zoledronic Acid Injection due to failed impurities testing. This medication may contain harmful substances that could cause health issues. Affected units have specific batch numbers and expiration dates.
Lower-risk recall
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Contact the company & request your remedy
What happened, in plain English
Dr. Reddy's is recalling Zoledronic Acid Injection because it failed impurities testing. This could mean the product contains harmful substances that might cause health problems. The recall affects specific batch numbers and expiration dates. Read more at govinfonow.com/recall/39568-dr-reddy-s-zoledronic-acid-injection-recall-failed-impurities-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39568-dr-reddy-s-zoledronic-acid-injection-recall-failed-impurities-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-0104-2019
Cite this page
“Dr. Reddy's Zoledronic Acid Injection Recall: Failed Impurities Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39568-dr-reddy-s-zoledronic-acid-injection-recall-failed-impurities-risk. Based on FDA recall #D-0104-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0104-2019%22&limit=1).
Why it’s dangerous
The product failed impurities testing, meaning it may contain harmful substances not supposed to be in the medication. This could lead to health issues if the medication is used as intended.
Who’s affected
Patients prescribed Zoledronic Acid Injection by a doctor are affected. Those with the specific batch numbers listed in the recall notice are most at risk.
How to tell if you have this one
Check the product label for the batch numbers BS704 (exp 12/018), BS725 (exp 6/2019), or BS745 (exp 11/2019). The product is a 100ml single-dose bottle for prescription use only.
- Brand
Dr. Reddy's- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States.
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| 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; Batch Numbers: BS633, EXP 9/2018; BS701, BS702, BS703, EXP 12/2018; BS708, BS709, BS711, BS712, BS713, BS714, BS715, EXP 3/2019; BS726, BS727, EXP 6/2019; BS728, BS729, BS730, EXP 7/2019; BS801, EXP 03/2020.. | 59,468 vials | 55111-688-52 |
| 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; Batch Numbers: BS704, EXP 12/018; BS725, EXP 6/2019; BS745, EXP 11/2019. | 10,530 vials | 43598-331-11 |
What to do — step by step
Check Product Label
Look for batch numbers BS704, BS725, or BS745 on the label.
Questions people ask
Is this product safe to use?
The product has failed impurities testing and may contain harmful substances, so it is not safe to use as recalled.
What should I do if I have this product?
The recall does not specify a remedy, so check the product label for batch numbers and contact your doctor or the manufacturer for guidance.
How can I tell if I have the recalled product?
Check the label for batch numbers BS704 (exp 12/018), BS725 (exp 6/2019), or BS745 (exp 11/2019).
Contact Dr. Reddy's
We’ve drafted a message you can send Dr. Reddy's to request your refund or repair — edit it as you like.
Subject: Recall D-0104-2019 — Dr. Reddy's Dr. Reddy's Hello, I own a Dr. Reddy's that is covered by recall D-0104-2019 from Dr. Reddy's. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Similar recalls
Keep exploring
From people who’ve dealt with this
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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-0104-2019 (September 12, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0104-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.