Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

TORISEL Kit (temsirolimus) injection Recalled by Pfizer Inc. Due to Crystallization: Impurities in a raw material used to...

Date: October 10, 2014
Company: Pfizer Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Pfizer Inc. directly.

Affected Products

TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL and 1 vial of 2.2 mL DILUENT per carton, Rx only, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101; Diluent  MADE IN ITALY; NDC 0008-1179-01.

Quantity: 16,000 kits

Why Was This Recalled?

Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold storage. The TORISEL vials are not affected by this issue.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Pfizer Inc.

Pfizer Inc. has 114 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report