TORISEL Kit — Class III drug recall D-0235-2015
Terminated recall by Pfizer Inc., reported 2014-11-12, distributed nationwide. Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of cryst
| Recall number | D-0235-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2014-10-10 |
| Classified | 2014-11-04 |
| Reported by FDA | 2014-11-12 |
| Terminated | 2017-04-14 |
| Distributed | Nationwide (US) |
| Quantity | 16,000 kits |
| Reason classes | specification failure |
| NDC | 00008-1125-01, 00008-1179, 00008-1179-01, 00008-1279-01 |
| Lot numbers | 05/16, AHZW/11, AHZW/12, AIEM/13 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0235-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.