Food, drugs, devices › Mylan Institutional LLC

Drug recall: Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, packaged in 5 x 2 mL vials per carton, Rx only

FDA enforcement event 70936 · Class I · initiated 18 Mar 2015 · status Terminated · terminated 29 Jun 2016

DrugVoluntary: Firm initiated1 product recordRockford, IL

Mylan Institutional LLC (Rockford, IL) initiated this drug recall on 18 Mar 2015; FDA lists 1 product record under event 70936, 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. 17% of the 292 drug enforcement events initiated in 2015 carry the same class.

Status: Terminated, terminated 29 Jun 2016. Initiation: voluntary: firm initiated. Mylan Institutional LLC has 11 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

Mylan Institutional LLC, Rockford, IL.

Reason for recall

"Presence of Particulate Matter"

Distribution

"Nationwide and Puerto Rico"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-1328-2015	Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, packaged in 5 x 2 mL vials per carton, Rx only, labeled as a) Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-0146-01; and b) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-467-99.	a) 15,095 vials b) 300 vials	Class I	Terminated	19 Aug 2015

Context

17%of 2015 drug events are Class I292 events that year

1product record in this eventfirm median: 1

11events on this register for the firm

Other enforcement events for Mylan Institutional LLC

Initiated	Product (first record)	Type	Class	Records
3 May 2021	Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 25 (2 mL multi-dose vial) per carton, Rx onl	Drug	Class III	1
17 Aug 2020	Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial (NDC 67457-153-99); 10 x 9 mL Sin	Drug	Class I	2
7 Jul 2020	Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan Institutional, LLC, R	Drug	Class I	1
5 May 2020	Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC,	Drug	Class II	1
23 Apr 2015	Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-0152-01), packaged in 10 x 5 mL Vials per c	Drug	Class I	1
23 Mar 2015	Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only, labeled as a) Manufactur	Drug	Class I	3
18 Mar 2015	CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Multi-Dose Vial, Rx only, Manufactured for: My	Drug	Class I	1
18 Feb 2015	Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) packa	Drug	Class II	2
11 Feb 2015	DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use Only, Sterile, ISOTONIC SOLUTION, Caution:	Drug	Class III	1
23 Jan 2015	Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for:	Drug	Class III	1

All 11 events for Mylan Institutional LLC

Questions and answers

Why was this drug recalled?

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

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 and Puerto Rico"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 29 Jun 2016. "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.