CLASS III Drug recall · Reported 2 Mar 2022 · FDA Enforcement Report
Bortezomib, 3.5 mg/vial, Single-Dose Vial recalled
Dr. Reddy's Laboratories is recalling Bortezomib, 3.5 mg/vial, Single-Dose Vial, distributed nationwide in the US. The recall was initiated on 19 Jan 2022 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0577-2022
- FDA event ID
- 89447
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 19 Jan 2022
- FDA classified
- 22 Feb 2022
- Reported
- 2 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 19 Jan 2022 | Recall initiated by company | |
| 22 Feb 2022 | Classified by FDA | +34 days |
| 2 Mar 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed stability specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Failed stability specifications
Which lots are affected?
Lot # H210233, Exp 3/1/2023
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 89447This product is part of a recall event; the main page for the event is Azacitidine, 1,00mg/Vial, One Single-dose Vial recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Azacitidine, 1,00mg/Vial, One Single-dose Vial recalledAzacitidine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide | |
| CLASS III | Azacitidine, 100mg/vial, One Single-dose Vial recalledAzacitidine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
More recalls from Dr. Reddy's Laboratories
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalledSuccinylcholine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS I | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
Other Bortezomib recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bortezomib for Injection 3.5mg/Vial per Single-Dose Vial recalled | Reliance Life Sciences Private | Sterility | Nationwide |
| Drug | CLASS II | Bortezomib 2.5 mg / SQ Syringe recalled by Infusion Options | Infusion Options | Sterility | NY |