Recall Register

Food, drugs, devices › Firms

Pfizer

FDA recalling firm · 4 enforcement events · 4 product records · 2018–2026 · NY, IL

Pfizer has 4 FDA enforcement events on this register (4 product records) between 2018 and 2026: 4 drug; the busiest year was 2018 with 1.

25% of its events are Class I; the most common class is Class II (3). 3 events are listed as ongoing; the recalling firm's address is in NY and IL.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
4 Sep 2026Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Vial NDC 0409-5820-11, Carton NDC 0409-5820-01.DrugClass II1Ongoing
29 Jul 2025Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx only, Distributed by: Pfizer Inc., New York, NY 10017, Made in Austria, NDC 60793-851-01.DrugClass II1Ongoing
21 Dec 2023Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc., Lake Forest, IL 68045, NDC 61703-332-18DrugClass I1Ongoing
28 Jun 2018Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-0106-01.DrugClass II1Terminated

By type and class

Drug4
Class II3
Class I1

Class I: 25% of this firm's events; 18% of all events on the register.

Events by year

18
19
20
21
22
23
24
25
26
Enforcement events for Pfizer by year initiated.

Questions and answers

How many FDA recalls has Pfizer had?

4 enforcement events (4 product records) on this register, 2018–2026: 4 drug.

Are any Pfizer recalls ongoing?

3 events are listed as ongoing in the current openFDA export.

What class are Pfizer recalls?

3 Class II, 1 Class I. 25% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.