FDA recall, , Moderate risk
Somerset Therapeutics Pemetrexed, Bortezomib and Azacitidine for Injection
Pemetrexed, Bortezomib, and Azacitidine for Injection lack sterility assurance.
Summary by Recall Canary from the FDA notice
What happened
Reliance Life Sciences Private Limited of Navi Mumbai, India, recalled Pemetrexed for Injection 500mg/Vial, Pemetrexed for Injection 100mg/Vial, Bortezomib for Injection 3.5mg/Vial, and Azacitidine for Injection 100mg/Vial due to cGMP Deviations, which the FDA states can result in a lack of sterility assurance.
The products were distributed nationwide in the USA and are manufactured for Somerset Therapeutics, LLC. The recall began June 24, 2026, and was added to the FDA's Enforcement Report on July 8, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match your product and all the details in one listed combination.
An NDC (National Drug Code) is usually printed on the drug's label.
Pemetrexed for Injection
- Strength
- 500 mg
- NDC
- 70069-0835-01
- Lot code
- RPTH0125A
- Strength
- 100 mg
- NDC
- 70069-0834-01
- Lot code
- RPTL0325A
Bortezomib for Injection
- Strength
- 3.5 mg
- NDC
- 70069-0836-01
- Lot code
- RBIH0125A
Azacitidine for Injection
- Strength
- 100 mg
- NDC
- 70069-0857-01
- Lot code
- RAZM0425A
Recall details
- Company began the recall
- Sold in
Nationwide in the USA
- Company
- Reliance Life Sciences Private LimitedNavi Mumbai, India
- Hazard
- Manufacturing problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99312
- Recall numbers
- D-0671-2026 to D-0674-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
