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Hospira Inc., A Pfizer Company

FDA Regulatory Profile

Hospira Inc., A Pfizer Company has 10 FDA recalls (2 Class I), 0 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Hospira Inc., A Pfizer Company" and its spelling variants "Hospira Inc., A Pfizer", "Hospira Inc. A Pfizer". Records filed under related names are not included; see Related names.

Latest recall: D-0576-2018 · Class II · Feb 20, 2018

Newer recall under related name Pfizer: Sep 29, 2026, D-0052-2027.

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	10 (2 Class I)	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	0	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Hospira Inc., A Pfizer Company's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Recall records	Class I
2026	0	0
2025	0	0
2024	0	0
2023	0	0
2022	0	0
2021	0	0
2020	0	0
2019	0	0
2018	1	0
2017	4	1

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Related names

Each name below has its own page. Its counts cover only the records FDA filed under that name and are not part of the totals for Hospira Inc., A Pfizer Company above.

Name	Relation	Recalls	510(k)	Inspections	Compliance actions	Most recent recall
Pfizer	Same company group	129	30	47	3	Sep 29, 2026 (D-0052-2027)
Hospira Inc, Lake Forest	Same company group	4	0	0	0	Jun 4, 2018 (D-0906-2018)
Pfizer Manufacturing Deutschland	Same company group	1	0	8	0	Sep 27, 2017 (D-0212-2018)
Hospira A Pfizer	Same company group	4	0	0	0	Jun 15, 2017 (D-1049-2017)
Hospira	Same company group	257	45	50	3	Apr 21, 2017 (D-0862-2017)
Pfizer Us Pharmaceutical Group	Same company group	4	0	0	0	Apr 16, 2014 (D-1409-2014)
Pfizer Ireland Pharmaceuticals Unlimited	Same company group	0	0	25	0	—
Wyeth Pharmaceutical Division Of Wyeth Holdings	Same company group	0	0	17	0	—
Hospira Australia	Same company group	0	0	6	1	—
Pfizer Health	Same company group	0	0	7	0	—
Hospira Worldwide	Same company group	0	0	6	0	—
Pfizer Asia Manufacturing	Same company group	0	0	6	0	—

Recent recalls

10 recall records from Jul 28, 2016 to Feb 20, 2018.

Number	Class	Product	Date
D-0576-2018	Class II	Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only…	Feb 20, 2018
D-0980-2017	Class III	Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile…	Jul 6, 2017
D-0898-2017	Class II	Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc…	May 18, 2017
D-0480-2017	Class II	METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container, Rx only, For…	Feb 10, 2017
D-0638-2017	Class I	Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct…	Jan 24, 2017
Z-1682-2017	Class II	Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids…	Dec 30, 2016
D-0097-2017	Class II	Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx…	Sep 16, 2016
D-0096-2017	Class II	Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial…	Sep 16, 2016
D-0218-2017	Class I	Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose…	Aug 4, 2016
Z-2790-2016	Class II	Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and…	Jul 28, 2016

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