CLASS II ONGOING Drug recall · Reported 15 Jul 2026 · FDA Enforcement Report
Bortezomib for Injection 3.5mg/Vial per Single-Dose Vial recalled
Reliance Life Sciences Private is recalling Bortezomib for Injection 3.5mg/Vial per Single-Dose Vial, For Intravenous or Subcutaneous, distributed nationwide in the US. The recall was initiated on 24 Jun 2026 and the FDA has classified it as Class II.
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-0673-2026
- FDA event ID
- 99312
- Recalling firm
- Reliance Life Sciences Private, Navi Mumbai, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Jun 2026
- FDA classified
- 8 Jul 2026
- Reported
- 15 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 24 Jun 2026 | Recall initiated by company | |
| 8 Jul 2026 | Classified by FDA | +14 days |
| 15 Jul 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Sterility Assurance
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873. NDC: 70069-0836-01
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Lack of Sterility Assurance
Which lots are affected?
Lot, expiry: RBIH0125A Jan 31, 2028; RBIH0225A Feb 29, 2028; RBIH0325A Feb 29, 2028; RBIH0525A Mar 31, 2028
Where was it sold?
Nationwide in the USA
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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
3 other products · FDA event 99312This product is part of a recall event; the main page for the event is Pemetrexed for Injection 500mg/Vial-Dose Vial recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Pemetrexed for Injection 500mg/Vial-Dose Vial recalled | Reliance Life Sciences Private | Sterility | Nationwide | |
| CLASS II | Pemetrexed for Injection 100mg/Vial-Dose Vial recalled | Reliance Life Sciences Private | Sterility | Nationwide | |
| CLASS II | Azacitidine for Injection 100mg/Vial-Dose Vial recalled | Reliance Life Sciences Private | Sterility | Nationwide |
More recalls from Reliance Life Sciences Private
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Azacitidine for Injection 100mg/Vial-Dose Vial recalled | Reliance Life Sciences Private | Sterility | Nationwide |
| Drug | CLASS II | Pemetrexed for Injection 100mg/Vial-Dose Vial recalled | Reliance Life Sciences Private | Sterility | Nationwide |
| Drug | CLASS II | Pemetrexed for Injection 500mg/Vial-Dose Vial recalled | Reliance Life Sciences Private | Sterility | Nationwide |
Other Bortezomib recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Bortezomib, 3.5 mg/vial, Single-Dose Vial recalled | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Bortezomib 2.5 mg / SQ Syringe recalled by Infusion Options | Infusion Options | Sterility | NY |