The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0575-2022·Announced 2022-03-02

Dr. Reddy's Azacitidine Injectable Drug Recalled for Failed Stability

Dr. Reddy's Laboratories is recalling Azacitidine 100mg injectable vials nationwide due to failed stability specifications. Multiple lot numbers distributed across the United States are affected.

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: This is an FDA Class III recall with no reported illnesses or injuries. The hazard is stability failure, which is a quality/integrity issue rather than an acute safety threat. The source text contains no evidence of harm or hospitalization.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Azacitidine (azacitidine) 100mg/vial, a prescription injectable medication used intravenously or subcutaneously, due to failed stability specifications.

The recall affects 68,061 vials distributed nationwide in the United States. The affected lots include: H200101, H200102, H200099, H200100, H200106 (expiration 8/1/2023); H210015, H210014, H210013 (expiration 11/1/2023); H210086 (expiration 12/1/2023); H210130 (expiration 1/1/2024); H210171, H210172, H210173, H210174 (expiration 2/1/2024); H210196, H210197 (expiration 3/1/2024); H210283, H210282 (expiration 4/1/2024); and H210382, H210381, H210419, H210420 (expiration 7/1/2024), H210445 (expiration 8/1/2024).

Patients using this medication should contact their healthcare provider or pharmacist to determine if their vial is part of the recall. Healthcare providers should not dispense affected lots. The product is manufactured by Dr. Reddy's Laboratories Limited, Visakhapatnam, India, and bears NDC 43598-305-62.

The recalled product

Product
AZACITIDINE (AZACITIDINE)
Brand
AZACITIDINE
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Injectable / Prescription
Hazard
Affected units
68,061

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 (20)

  • Lot #: H200101
  • H200102
  • H200099
  • H200100 & H200106
  • Exp 8/1/2023
  • H210015
  • H210014 & H210013
  • Exp 11/1/2023
  • H210086
  • Exp 12/1/2023
  • H210130
  • Exp 1/1/2024
  • H210171
  • H210172
  • H210173
  • H210174
  • Exp 2/1/2024
  • H210196 & H210197
  • Exp 3/1/2024
  • H210283 & H210282

UPCs (1)

  • 0343598305622

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 →

Related recalls

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Same hazard · stability failure

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