Bortezomib for Injection Recall Issued by Reliance Life Sciences
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Reliance Life Sciences Private Limited is recalling 11,400 vials of Bortezomib for Injection due to lack of sterility assurance. The Class II recall affects specific lots distributed nationwide in the USA.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 8, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Reliance Life Sciences Private Limited initiated a voluntary recall due to lack of sterility assurance for Bortezomib for Injection.
Which Products Are Affected
Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use, NDC: 70069-0836-01. Affected lots include RBIH0125A (exp. Jan 31, 2028), RBIH0225A (exp. Feb 29, 2028), RBIH0325A (exp. Feb 29, 2028), and RBIH0525A (exp. Mar 31, 2028). A total of 11,400 vials are affected. The product was manufactured for Somerset Therapeutics, LLC. Distribution was nationwide in the USA. Recall number: D-0673-2026.
What You Should Do
Consumers and healthcare providers should stop using the affected product. Contact the recalling firm or healthcare provider for further guidance on returns or alternatives.
Why This Matters
Lack of sterility assurance in injectable drugs poses a potential risk of infection for patients requiring this medication.
Source
FDA recall D-0673-2026. Data from FDA enforcement report.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,041 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.