The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0576-2022·Announced 2022-03-02

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.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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.
Category
Drug — Intravenous/Subcutaneous Injectable
Hazard
Affected units
18,261

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.

Part of a larger recall action

This product is one of 3 recalled by Dr. Reddy's Laboratories, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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