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Pfizer

Pharmaceutical companyAI in United StatesAI. FDA records under 15 spellings of its name, each linked to the record. See the Pfizer group view.

  • Records across the group: 2,534, 64 entitiesAI
  • Drug applications: 1,378
  • 510(k) clearances: 716
  • Drug recalls: 312
  • Device recalls: 115

Records by Year

Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Pfizer and its 63 subsidiaries

Latest Records

Newest first across sources; each opens the record
DateRecordSource
Apr 8, 2026Untitled letter: ADCETRISOffice of Prescription Drug PromotionOPDP letters
Sep 9, 2025Untitled letter: VELSIPITYOffice of Prescription Drug PromotionOPDP letters
Jan 17, 2025Complete response letter, NDA 219112UnapprovedComplete response letters
Feb 8, 2023Warning letter: DrugsCDERWarning letters
Jan 21, 2022Complete response letter, BLA 761184ApprovedComplete response letters
Mar 25, 2020Warning letter: Data integrity, Sterility assurance, Out-of-specificationCDERWarning letters
Mar 4, 2019Warning letter: Data integrity, Aseptic processing, Sterility assuranceCDERWarning letters
Sep 15, 2018ThermaCare Quick Therapy TENSK181102 · NUH510(k) clearances
Jun 19, 2018Untitled letter: ESTRINGOffice of Prescription Drug PromotionOPDP letters
Apr 20, 2018Complete response letter, BLA 761081ApprovedComplete response letters
Mar 19, 2018Complete response letter, NDA 210282ApprovedComplete response letters
Feb 22, 2018Complete response letter, NDA 209191ApprovedComplete response letters
Nov 3, 2017Complete response letter, NDA 209191ApprovedComplete response letters
Sep 27, 2017FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk, b) 40 mg SMT G EP PR KR, c) 20 mg SMT G EP PR, d) 20 mg SMTClass II · Microbial Contamination of Non-Sterile ProductsDrug recalls
Mar 28, 2017Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleK161469 · FRN510(k) clearances
Jan 6, 2017Hospira Extension Set, Hospira Primary SetK161036 · FPA510(k) clearances
Dec 6, 2016Hospira Sapphire SetsK160492 · MRZ510(k) clearances
Oct 21, 2016Paragon 2K162687 · IZL510(k) clearances
Jun 1, 2016Hospira Administration SetsK160870 · FPA510(k) clearances
Apr 8, 2016LifeCare PCA Infusion SystemK143612 · MEA510(k) clearances
Mar 4, 2015Hospira Blood SetK143087 · FPA510(k) clearances
Aug 2, 2012Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045. For use with a compClass II · Reports of leaking during filling and administration.Device recalls
May 15, 2009Complete response letter, NDA 022377ApprovedComplete response letters

Subsidiaries and Divisions

63 firms in the Pfizer group, most records first

Canada and Imports

Across the Pfizer group, matched by company name
FDA import refusals since 2024
130 shipment lines, through Oct 23, 2026

Names and Identifiers

Appears as
PFIZERPfizer Inc.Pfizer, Inc.PFIZER INCPfizer IncPfizerPFIZER, INCPfizer, IncPFIZER GLOBAL
Website
pfizer.com
Wikidata
Q206921

Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.