Why it was recalled
Lack of Sterility Assurance
Product description
Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0835-01
Lot numbers, UPCs & expiration codes
Lot, expiry: RPTH0125A Jan 31, 2028; RPTH0225A Jan 31, 2028; RPTH0325A Jan 31, 2028; RPTH0725A Apr 30, 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-0672-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 24, 2026
- FDA report date
- Jul 15, 2026
- Quantity
- 5,020 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Reliance Life Sciences Private Limited
Original FDA data
Every field from FDA enforcement report D-0672-2026, 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: RPTH0125A Jan 31, 2028; RPTH0225A Jan 31, 2028; RPTH0325A Jan 31, 2028; RPTH0725A Apr 30, 2028;
- Report date
- Jul 15, 2026
- Product type
- Drugs
- Recall number
- D-0672-2026
- Classification
- Class II
- Recalling firm
- Reliance Life Sciences Private Limited
- Product quantity
- 5,020 vials
- Reason for recall
- Lack of Sterility Assurance
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0835-01
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 24, 2026
- Initial firm notification
- Letter
- Center classification date
- Jul 8, 2026