Drug recall: Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer…

Class II FDA enforcement event 94681. Recall start date: 20 May 2024. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Lack of Assurance of Sterility-The potential for incomplete crimp seals.

Class II, in the words of FDA

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

Pfizer Inc. started this drug recall on 20 May 2024. The firm address in the FDA record is in New York, NY. FDA put the recall in Class II. FDA event 94681 has 2 product records. The first FDA enforcement report date is 3 Jul 2024. The record gives the status Ongoing.

FDA enforcement report The 2 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

US Nationwide and Puerto Rico.

Recalling firm

Pfizer Inc., New York, NY.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

2 product records in the event.

FDA event 94681: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0564-2024	Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intramuscular or Intravenous Use, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2012-03	84,710 cartridges	Class II	Ongoing	3 Jul 2024
D-0565-2024	Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intravenous Injection Only, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2339-24	220,400 cartridges	Class II	Ongoing	3 Jul 2024

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2024: 319
Share of these events in Class II: 71%
Product records in this event: 2Median of the firm: 1
Events of the firm on the register: 72

Other events of the firm

Other FDA enforcement events of 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
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
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

Pfizer Inc.: all 72 events

Official channels

FDA enforcement report D-0564-2024The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 94681. https://recallregister.com/fda/ii/94681/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: US Nationwide and Puerto Rico.
What quantity of product is in FDA event 94681?: The event has 2 product records. The first record gives this quantity: 84,710 cartridges
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2024 have the same class?: 71% of the 319 drug events that started in 2024 are in Class II.