Bortezomib Injections Recalled Due to Lack of Sterility Assurance
Key Takeaways:
- The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for bortezomib injections, 3.5 mg per vial. The affected batches have been identified as Lots RBIH0125A (expires January 2028), RBIH0225A (expires February 2028), RBIH0325A (expires February 2028), and RBIH0525A (expires March 2028), affecting 11 400 vials.
- The recall was initiated by Reliance Life Sciences Private, Ltd due to the lack of sterility assurance, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
- Bortezomib injections are used to treat multiple myeloma and mantle cell lymphoma.
The FDA has issued a Class II recall for bortezomib injections, 3.5 mg per vial, affecting 11 400 vials. This product is being recalled by Reliance Life Sciences Private, Ltd based in Navi Mumbai, India. The recall was initiated on June 24, 2026, and received a Class II classification on July 8, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
The recall was initiated due to the product’s lack of sterility assurance. This deficiency affects Lots RBIH0125A (expires January 2028), RBIH0225A (expires February 2028), RBIH0325A (expires February 2028), and RBIH0525A (expires March 2028). Reliance Life Sciences Private sent out a public notice via letter; no press release has been issued for this recall.
Bortezomib injections are prescribed to treat multiple myeloma and mantle cell lymphoma. Pharmacists should identify and quarantine the affected Lots, remove them from inventory, and coordinate with prescribers to provide an alternative supply.
Reference
FDA. Enforcement Report. July 15, 2026. Accessed July 15, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221262
