Why it was recalled
Lack of Sterility Assurance
Product description
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
Lot numbers, UPCs & expiration codes
Lot, expiry: RBIH0125A Jan 31, 2028; RBIH0225A Feb 29, 2028; RBIH0325A Feb 29, 2028; RBIH0525A Mar 31, 2028
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0673-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 24, 2026
- FDA report date
- Jul 15, 2026
- Quantity
- 11,400 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Reliance Life Sciences Private Limited
Original FDA data
Every field from FDA enforcement report D-0673-2026, exactly as published.
Show all FDA fields
- City
- Navi Mumbai
- Status
- Ongoing
- Country
- India
- Event ID
- 99312
- Address
- Ttc Area Of Midc
- Address (line 2)
- R - 282 Dhirubhai Ambani Life Sciences Centre; Thane Belapur Road
- Code information
- Lot, expiry: RBIH0125A Jan 31, 2028; RBIH0225A Feb 29, 2028; RBIH0325A Feb 29, 2028; RBIH0525A Mar 31, 2028
- Report date
- Jul 15, 2026
- Product type
- Drugs
- Recall number
- D-0673-2026
- Classification
- Class II
- Recalling firm
- Reliance Life Sciences Private Limited
- Product quantity
- 11,400 vials
- Reason for recall
- Lack of Sterility Assurance
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 24, 2026
- Initial firm notification
- Letter
- Center classification date
- Jul 8, 2026