Zoledronic Acid Injection (Dr. Reddy's) – Impurity Specification Failure (2018)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Dr. Reddy's Laboratories, Inc.
Lot Codes / Batch Numbers
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..
Products Sold
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..
Dr. Reddy's Laboratories, Inc. is recalling Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited due to Failed Impurities/Degradation Specifications: OOS for unknown impurities.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026