Dr. Reddy's Azacitidine Recall: Failed Stability Specifications
Dr. Reddy's recalls certain Azacitidine vials due to failed stability specifications. This may affect drug effectiveness and safety. Check NDC 43598-305-62 and specific lot numbers for affected products.
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Failed stability specifications
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What happened, in plain English
Dr. Reddy's is recalling specific batches of Azacitidine vials because they failed stability tests. This could mean the medication becomes less effective or unsafe over time, especially if stored improperly. Read more at govinfonow.com/recall/35382-dr-reddy-s-azacitidine-recall-failed-stability-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/35382-dr-reddy-s-azacitidine-recall-failed-stability-specifications · Updated August 18, 2026 · FDA enforcement record: FDA #D-0575-2022
Cite this page
“Dr. Reddy's Azacitidine Recall: Failed Stability Specifications.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35382-dr-reddy-s-azacitidine-recall-failed-stability-specifications. Based on FDA recall #D-0575-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0575-2022%22&limit=1).
Why it’s dangerous
The vials failed stability specifications, meaning the medication may lose effectiveness or become unsafe if stored for longer than intended. This could impact treatment outcomes for patients using the drug.
Who’s affected
Patients prescribed Azacitidine by a doctor who received the recalled vials from Dr. Reddy's Laboratories. Those with the specific lot numbers listed in the recall are most at risk.
How to tell if you have this one
Check the NDC code 43598-305-62 on the vial label. Look for specific lot numbers like H200101, H200102, H200099, and others listed in the recall notice.
- Brand
Dr. Reddy's- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
USA Nationwide
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0575-2022 | Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-305-62; 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, Exp 4/1/2024; H210382, H210381, H210419 & H210420, Exp 7/1/2024, H210445, Exp 8/1/2024. | 68061 vials | 43598-305-62 |
| D-0576-2022 | Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-465-62; 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. | 18261 vials | 43598-465-62 |
| D-0577-2022 | Bortezomib, 3.5 mg/vial, Single-Dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-865-60; Lot # H210233, Exp 3/1/2023 | 2,980 vials | — |
What to do — step by step
Check Vial Label
Look for the NDC code 43598-305-62 and specific lot numbers listed in the recall.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What lot numbers are affected?
Lot numbers include H200101, H200102, H200099, H200100, H200106, H210015, H210014, H210013, and others as listed in the recall notice.
Do I need to stop using this product?
The recall does not require stopping use; it only identifies affected batches for verification.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0575-2022 (January 19, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0575-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.