Drug recall: 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial a

FDA enforcement event 93124 · Class I · initiated 2 Oct 2023 · status Terminated · terminated 14 Feb 2025

DrugVoluntary: Firm initiated3 product recordsNew York, NY

Pfizer Inc. (New York, NY) initiated this drug recall on 2 Oct 2023; FDA lists 3 product records under event 93124, classified Class I.

FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 15% of the 281 drug enforcement events initiated in 2023 carry the same class.

Status: Terminated, terminated 14 Feb 2025. Initiation: voluntary: firm initiated. Pfizer Inc. has 72 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Pfizer Inc., New York, NY.

Reason for recall

"Presence of Particulate Matter: identified as glass."

Distribution

"Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees."

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0100-2024	4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-5534-24	24,900 vials	Class I	Terminated	15 Nov 2023
D-0101-2024	1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 0409-4904-11	21,390 vials	Class I	Terminated	15 Nov 2023
D-0102-2024	2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 0409-4903-11	3,200 vials	Class I	Terminated	15 Nov 2023

Context

15%of 2023 drug events are Class I281 events that year

3product records in this eventfirm median: 1

72events on this register for the firm

Other enforcement events for 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
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
22 Aug 2022	PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0409-4699-54) further pa	Drug	Class I	1

All 72 events for Pfizer Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Presence of Particulate Matter: identified as glass."

What does Class I mean?

FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 14 Feb 2025. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.