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Lower risk Drug recall · FDA · Published May 23, 2024

Dr. Reddy's Zoledronic Acid Injection Recall: Leaking Vials Risk

Dr. Reddy's recalls Zoledronic Acid 5mg/100mL vials due to leaking, risking contamination. Affected lots: G3000010, expiring 11/2025. Contact for details.

🇺🇸 FDA recall #D-0510-2024DrugDr. Reddy's ›
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Recalling firmDr. Reddy's Laboratories, Inc.107 College Rd E · Princeton, NJ 08540-6623
✎ GovInfoNow plain-language explainer

Dr. Reddy's recalls Zoledronic Acid Injection vials that may leak, causing contamination risks. This affects patients receiving the drug under prescription. The recall is for safety, as leaking vials could lead to infections. Read more at govinfonow.com/recall/32656-dr-reddy-s-zoledronic-acid-injection-recall-leaking-vials-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/32656-dr-reddy-s-zoledronic-acid-injection-recall-leaking-vials-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0510-2024

Cite this page

“Dr. Reddy's Zoledronic Acid Injection Recall: Leaking Vials Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32656-dr-reddy-s-zoledronic-acid-injection-recall-leaking-vials-risk. Based on FDA recall #D-0510-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0510-2024%22&limit=1).

The FDA announced on May 23, 2024, that Dr. Reddy's Laboratories is recalling Zoledronic Acid Injection due to a lack of assurance of sterility caused by leaking vials. The agency issued recall number D-0510-2024 for the Class II voluntary recall.

How to tell if you have it

  • Brand: Dr. Reddy's
  • Product: Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials
  • NDC: 55111-688-52
  • Lot #: G3000010
  • Exp. Date: 11/2025
  • Quantity: 13,880 vials

The hazard

The recall addresses a lack of assurance of sterility resulting from leaking vials. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Dr. Reddy's Laboratories, Inc. has 85 other recalls on record since 2012-04-09. Other recent recalls of similar products include Dr. Reddy's Varenicline Tablets Recall (2025-11-11), Dr. Reddy's Succinylcholine Chloride Injection Recall (2025-09-26), and Dr. Reddy's Omeprazole Capsules Recall (2025-06-30). Other recent recalls of similar products include Reliance Azacitidine Injection Recall (2026-06-24), Reliance Pemetrexed Injection Recall (2026-06-24), and Reliance Bortezomib Injection Recall (2026-06-24).

How to tell if you have this one

Check for vials labeled 'Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only'. The lot number G3000010 and expiration date 11/2025 are specific to this recall.

  • Brand
    Dr. Reddy's
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Vial Details

    Look for the lot number G3000010 and expiration date 11/2025 on the vial label.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 13 days after the firm started it.

1. Firm started the recall: May 23, 202412. FDA classified it Class II: May 28, 202423. Published in FDA’s Enforcement Report: Jun 5, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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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-0510-2024 (May 23, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0510-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA