FDAClass IIJuly 15, 2026

Bortezomib for Injection 3.5mg/Vial recall: Sterility Concern

Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use, Manufactured for: Somerset Therapeutics, LLC.…

Why was Bortezomib for Injection 3.5mg/Vial recalled?

Lack of Sterility Assurance

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot, expiry: RBIH0125A Jan 31, 2028; RBIH0225A Feb 29, 2028; RBIH0325A Feb 29, 2028; RBIH0525A Mar 31, 2028

Product
Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use, Manufactured for: Somerset Therapeutics, LLC.…
Recalling firm
Reliance Life Sciences Private Limited
Quantity
11,400 vials
Distribution
Nationwide in the USA
Recall date
July 15, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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