Drug recall: HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc.,

FDA enforcement event 77956 · Class II · initiated 22 Aug 2017 · status Terminated · terminated 19 Feb 2023

DrugVoluntary: Firm initiated2 product recordsNew York, NY

FDA enforcement event 77956 is a drug recall by Pfizer Inc. of New York, NY, initiated 22 Aug 2017 and classified Class II, with 2 product records.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 57% of the 343 drug enforcement events initiated in 2017 carry the same class.

Status: Terminated, terminated 19 Feb 2023. 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

"Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process."

Distribution

"United States Nationwide (including Puerto Rico) and Singapore"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-1167-2017	HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3365-11 (carton) and 0409-3365-01(vial)	115,370 vials	Class II	Terminated	27 Sep 2017
D-1168-2017	Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL Fill in 5 mL Single dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3375-04	98,050 vials	Class II	Terminated	27 Sep 2017

Context

57%of 2017 drug events are Class II343 events that year

2product 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
2 Oct 2023	4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial a	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

All 72 events for Pfizer Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "United States Nationwide (including Puerto Rico) and Singapore"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 19 Feb 2023. "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.