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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Azacitidine and Bortezomib Recalled for Failed Stability Specifications

Agency Publication Date: February 22, 2022
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Summary

Dr. Reddy's Laboratories, Inc. is recalling 89,302 vials of Azacitidine (100mg) and Bortezomib (3.5mg) injectable medications. These medications, primarily used in hospitals and clinics for cancer treatment, were found to have failed stability specifications. This means the drugs may not maintain their quality, potency, or chemical composition until their labeled expiration date. No incidents or injuries related to this issue have been reported.

Risk

If a medication fails stability testing, it may become less effective over time or undergo chemical changes that could impact a patient's treatment. This recall ensures that only products meeting strict quality standards remain in clinical use.

What You Should Do

  1. This recall affects Azacitidine (100mg) and Bortezomib (3.5mg) injectable medications sold under the Dr. Reddy's Laboratories brand.
  2. To identify if your product is affected, check the NDC code (43598-305-62, 43598-465-62, or 43598-865-60) and the lot number and expiration date printed on the vial or carton. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product. Contact Dr. Reddy's Laboratories, Inc. or your distributor to arrange return.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Azacitidine Injectable (100mg/vial)
Variants: 100mg/vial, Single-dose Vial
Lot Numbers:
H200101 (Exp 8/1/2023)
H200102 (Exp 8/1/2023)
H200099 (Exp 8/1/2023)
H200100 (Exp 8/1/2023)
H200106 (Exp 8/1/2023)
H210015 (Exp 11/1/2023)
H210014 (Exp 11/1/2023)
H210013 (Exp 11/1/2023)
H210086 (Exp 12/1/2023)
H210130 (Exp 1/1/2024)
H210171 (Exp 2/1/2024)
H210172 (Exp 2/1/2024)
H210173 (Exp 2/1/2024)
H210174 (Exp 2/1/2024)
H210196 (Exp 3/1/2024)
H210197 (Exp 3/1/2024)
H210283 (Exp 4/1/2024)
H210282 (Exp 4/1/2024)
H210382 (Exp 7/1/2024)
H210381 (Exp 7/1/2024)
H210419 (Exp 7/1/2024)
H210420 (Exp 7/1/2024)
H210445 (Exp 8/1/2024)
NDC:
43598-305-62

Quantity: 68061 vials.

Product: Azacitidine Injectable (100mg/vial)
Variants: 100mg/vial, Single-dose Vial
Lot Numbers:
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)
NDC:
43598-465-62

Quantity: 18261 vials.

Product: Bortezomib Injectable (3.5mg/vial)
Variants: 3.5 mg/vial, Single-Dose Vial
Lot Numbers:
H210233 (Exp 3/1/2023)
NDC:
43598-865-60

Quantity: 2,980 vials.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89447
Status: Resolved
Manufacturer: Dr. Reddy's Laboratories, Inc.
Sold By: Hospitals; Clinics; Pharmacies
Manufactured In: India, United States
Units Affected: 3 products (68061 vials; 18261 vials; 2,980 vials)
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.