TORISEL Kit (Pfizer) – crystallization risk (2014)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Pfizer Inc.
Lot Codes / Batch Numbers
Kit Lot #: AIEM/13, Exp 05/16 that contain diluent lots AHZW/11 and AHZW/12
Products Sold
Kit Lot #: AIEM/13, Exp 05/16 that contain diluent lots AHZW/11 and AHZW/12
Pfizer Inc. is recalling TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL and 1 vial of 2.2 mL DILU due to Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold stor. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 12, 2026