Drug recall: Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, Rx only, Distributed by Pfizer Labs, Divisi

FDA enforcement event 81050 · Class II · initiated 19 Sep 2018 · status Terminated · terminated 26 Jun 2020

DrugVoluntary: Firm initiated1 product recordNew York, NY

FDA enforcement event 81050 is a drug recall by Pfizer Inc. of New York, NY, initiated 19 Sep 2018 and classified Class II, with 1 product record.

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. 60% of the 367 drug enforcement events initiated in 2018 carry the same class.

Status: Terminated, terminated 26 Jun 2020. 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 assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button."

Distribution

"U.S.A. nationwide. The following countries received product from Lot S91616: Albania, South Africa, Israel, Afghanistan, Rwanda, Botswana, Zimbabwe and Iraq as part of the Compassionate Use Program."

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0005-2019	Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, NDC 0069-0106-01	12,416 vials	Class II	Terminated	10 Oct 2018

Context

60%of 2018 drug events are Class II367 events that year

1product record 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 assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button."

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: "U.S.A. nationwide. The following countries received product from Lot S91616: Albania, South Africa, Israel, Afghanistan, Rwanda, Botswana, Zimbabwe and Iraq as part of the Compassionate Use Program."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 26 Jun 2020. "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.