Drug recall: 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…

Class III FDA enforcement event 69479. Recall start date: 10 Oct 2014. Status in the FDA record: Terminated. Termination date: 14 Apr 2017.

Reason for recall, in the words of 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.

Class III, in the words of FDA

a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

Pfizer Inc. started this drug recall on 10 Oct 2014. The firm address in the FDA record is in New York, NY. FDA put the recall in Class III. FDA event 69479 has 1 product record. The first FDA enforcement report date is 12 Nov 2014. The record gives the status Terminated, with the termination date 14 Apr 2017.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide and Puerto Rico

Recalling firm

Pfizer Inc., New York, NY.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 69479: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0235-2015	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.	16,000 kits	Class III	Terminated	12 Nov 2014

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class III: The lowest of the three FDA recall classes.

The event in context

Drug events that started in 2014: 313
Share of these events in Class III: 27%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 72

Other events of the firm

Other FDA enforcement events of Pfizer Inc.
Initiated	Product (first record)	Type	Class	Records
4 Aug 2025	Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 600	Drug	Class II	2
10 Jul 2025	Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed b	Drug	Class II	2
28 May 2025	DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, F	Drug	Class II	1
20 May 2024	Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock	Drug	Class II	2
21 Dec 2023	4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use	Drug	Class I	3
2 Oct 2023	4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial a	Drug	Class I	3
8 Mar 2023	MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholly owned su	Drug	Class III	1
29 Dec 2022	Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case	Drug	Class II	1
22 Dec 2022	Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials per carton,	Drug	Class I	1
27 Sep 2022	Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distributed by Hospira, Inc. La	Drug	Class II	1

Pfizer Inc.: all 72 events

Official channels

FDA enforcement report D-0235-2015The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 69479. https://recallregister.com/fda/iii/69479/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide and Puerto Rico
What quantity of product is in FDA event 69479?: The FDA record gives this quantity: 16,000 kits
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2014 have the same class?: 27% of the 313 drug events that started in 2014 are in Class III.