Dr. Reddy's Recalls Zoledronic Acid Injection Due to Sterility Concerns
Dr. Reddy's Laboratories is recalling 3,342 vials of Zoledronic Acid Injection due to defective seals that may compromise sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility in an intravenous injection, which poses a significant risk of infection or serious injury.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling 3,342 vials of Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle. The product is identified by Lot BS523 with an expiration date of 10/2017 and NDC 55111-688-52. The recall was initiated because of a lack of assurance of sterility caused by defective seals where the metal silver ring was not attached tightly to the vial.
The affected product was distributed nationwide. This is a prescription-only medication administered via the intravenous route. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should stop using the affected vials and contact Dr. Reddy's Laboratories for further instructions or a replacement. Consumers should verify the lot number and expiration date on their medication packaging to determine if it is affected.
The recalled product
- Product
- ZOLEDRONIC ACID (ZOLEDRONIC ACID)
- Brand
- ZOLEDRONIC ACID
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Injection
- Affected units
- 3,342
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot BS523
- exp 10/2017
UPCs (1)
- 0355111688525
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · ZOLEDRONIC ACID
- HighZoledronic Acid Injection Recalled for Sterility Defect
FDA (Drugs) · 2024-06-05
- LowDr. Reddy's Recalls Zoledronic Acid Injection Due to Unknown Impurities
FDA (Drugs) · 2018-10-03
- LowDr. Reddy's Recalls Zoledronic Acid Injection Due to Unknown Impurities
FDA (Drugs) · 2018-10-03
- SevereSagent Recalls Zoledronic Acid Injection Due to Sterility Concerns
FDA (Drugs) · 2014-10-08
Same manufacturer · Dr. Reddy's Laboratories, Inc.
See all →- ModerateVarenicline tablets recalled after an assay value fell below specification
FDA (Drugs) · 2025-12-17
- Moderate
- HighOmeprazole capsule bottle contained a foreign divalproex sodium tablet
FDA (Drugs) · 2025-07-23
- SevereLevetiracetam Injection Label Mismatch Nationwide Recall
FDA (Drugs) · 2025-04-23
- ModerateFDA Recalls JAVYGTOR Tablets Due to Failed Impurities and Degradation Specifications
FDA (Drugs) · 2024-12-18
Same hazard · sterility
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereFDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SevereROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29