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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Dr. Reddy's Laboratories, Inc.: Zoledronic Acid Injection Recalled for Unknown Impurities

Agency Publication Date: September 26, 2018
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Summary

Dr. Reddy's Laboratories, Inc. is voluntarily recalling 69,998 vials of Zoledronic Acid Injection, 5mg/100 mL, including those under the NOVAPLUS brand name. This recall was initiated because the medication failed to meet impurity and degradation specifications during testing, meaning unknown substances were found in the vials that should not be there. This prescription drug was distributed to retailers, distributors, medical facilities, and physician offices across the United States between 2018 and 2020.

Risk

The presence of unknown impurities or degradation products in an injectable medication may lead to unexpected side effects or reduced effectiveness of the treatment. While the risk level is currently categorized as low, impurities in an intravenous drug bypass the body's natural defenses and can cause adverse reactions.

What You Should Do

  1. Check your medication vials and packaging for the name Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) in a 100ml vial or single-dose bottle.
  2. Verify the NDC number on the label. For standard vials, look for NDC 55111-688-52. For NOVAPLUS brand bottles, look for NDC 43598-331-11.
  3. Compare the batch and expiration details on your product. Affected standard vials include batch 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), and BS801 (Exp 03/2020).
  4. Affected NOVAPLUS bottles include batches BS704 (Exp 12/2018), BS725 (Exp 6/2019), and BS745 (Exp 11/2019).
  5. If you have an affected product, contact your healthcare provider or pharmacist immediately for guidance on alternatives and to determine if your specific dose was impacted.
  6. Return any unused product to the pharmacy or medical facility where it was obtained for a refund, and contact Dr. Reddy's Laboratories at 1-888-723-3332 for further instructions regarding the return process.
  7. Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare guidance and product refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial
Model:
NDC 55111-688-52
Lot Numbers:
BS633 (Exp 9/2018)
BS701 (Exp 12/2018)
BS702 (Exp 12/2018)
BS703 (Exp 12/2018)
BS708 (Exp 3/2019)
BS709 (Exp 3/2019)
BS711 (Exp 3/2019)
BS712 (Exp 3/2019)
BS713 (Exp 3/2019)
BS714 (Exp 3/2019)
BS715 (Exp 3/2019)
BS726 (Exp 6/2019)
BS727 (Exp 6/2019)
BS728 (Exp 7/2019)
BS729 (Exp 7/2019)
BS730 (Exp 7/2019)
BS801 (Exp 03/2020)
Date Ranges: Expiration 9/2018 - 03/2020
Product: NOVAPLUS Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bottle
Model:
NDC 43598-331-11
Lot Numbers:
BS704 (Exp 12/2018)
BS725 (Exp 6/2019)
BS745 (Exp 11/2019)
Date Ranges: Expiration 12/2018 - 11/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81012
Status: Resolved
Manufacturer: Dr. Reddy's Laboratories, Inc.
Sold By: retailers; distributors; physician offices; medical facilities
Manufactured In: United States, India
Units Affected: 2 products (59,468 vials; 10,530 vials)
Distributed To: Nationwide
Agency Last Updated: October 27, 2018

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.