Why it was recalled
Lack of Sterility Assurance
Product description
Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0857-01
Lot numbers, UPCs & expiration codes
Lot, expiry: RAZM0425A Jun 30, 2027; RAZM0525A Jun 30, 2027; RAZM0725A Jun 30, 2027; RAZM0825A Jun 30, 2027; RAZM0925A Jul 31, 2027; RAZM1125A Jul 31, 2027; RAZM1225A Jul 31, 2027; RAZM1425A Jul 31, 2027; RAZM1525A Jul 31, 2027; RAZM1625A Aug 31, 2027; RAZM1725A Aug 31, 2027; RAZM2025A Sep 30, 2027
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-0674-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 24, 2026
- FDA report date
- Jul 15, 2026
- Quantity
- 8,001 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Reliance Life Sciences Private Limited
Original FDA data
Every field from FDA enforcement report D-0674-2026, 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: RAZM0425A Jun 30, 2027; RAZM0525A Jun 30, 2027; RAZM0725A Jun 30, 2027; RAZM0825A Jun 30, 2027; RAZM0925A Jul 31, 2027; RAZM1125A Jul 31, 2027; RAZM1225A Jul 31, 2027; RAZM1425A Jul 31, 2027; RAZM1525A Jul 31, 2027; RAZM1625A Aug 31, 2027; RAZM1725A Aug 31, 2027; RAZM2025A Sep 30, 2027
- Report date
- Jul 15, 2026
- Product type
- Drugs
- Recall number
- D-0674-2026
- Classification
- Class II
- Recalling firm
- Reliance Life Sciences Private Limited
- Product quantity
- 8,001 vials
- Reason for recall
- Lack of Sterility Assurance
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0857-01
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 24, 2026
- Initial firm notification
- Letter
- Center classification date
- Jul 8, 2026