Azacitidine 100mg Intravenous/Subcutaneous Drug Recall
Dr. Reddy's Laboratories is recalling Azacitidine 100mg vials distributed nationwide due to failed stability specifications. The recall affects six lots with expiration dates ranging from August 2023 to April 2024.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this recall as Class III, which typically corresponds to a severity score of 1 or 2. The source text identifies only a stability failure with no reported illnesses or injuries, supporting a Moderate rating rather than Low given the pharmaceutical nature of the product and the failure of quality assurance specifications.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Azacitidine 100mg single-dose vials (NDC 43598-465-62) distributed nationwide in the United States due to failed stability specifications.
The recalled product is a prescription intravenous and subcutaneous nucleoside metabolic inhibitor used in cancer treatment. A total of 18,261 vials are affected across six lots: H200107 (expiration 8/1/2023), H200154 (expiration 9/1/2023), H210020 (expiration 11/1/2023), H210055 (expiration 12/1/2023), H210129 (expiration 1/1/2024), and H210288 (expiration 4/1/2024). The drug is manufactured by Dr. Reddy's Laboratories Limited in Visakhapatnam, India.
Healthcare providers and patients currently using or holding these specific lots should contact their pharmacy or healthcare provider. Patients should not stop taking their medication without medical guidance.
The recalled product
- Product
- AZACITIDINE (AZACITIDINE)
- Brand
- AZACITIDINE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Hazard
- stability-failure
- failed-specifications
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 (12)
- Lot#: H200107
- Exp 8/1/2023
- H200154
- Exp 9/1/2023
- H210020
- Exp 11/1/2023
- H210055
- Exp 12/1/2023
- H210129
- Exp 1/1/2024
- H210288
- Exp 4/1/2024.
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · AZACITIDINE
- ModeratePrescription Injectable Azacitidine Recalled for Subpotent Assay Results
FDA (Drugs) · 2022-08-17
- ModerateDr. Reddy's Azacitidine Injectable Drug Recalled for Failed Stability
FDA (Drugs) · 2022-03-02
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27