The Recall Desk

Manufacturer

Mylan Institutional LLC

15 recalls in our database name Mylan Institutional LLC as the manufacturing or recalling firm.

What the numbers show

Total
15
Critical
4
Severe
7
Most recent
2021-06-09

Of the 15 recalls from Mylan Institutional LLC we have scored against our rubric, 4 (27%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 7 (47%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–15 of 15

  • LowFDA (Drugs)·D-0601-2021·2021-06-09

    Thiamine HCl Injection Recall: Vials with Incorrect Lot Numbers

    Mylan Institutional LLC is recalling Thiamine Hydrochloride Injection USP 200 mg/2 mL due to vials labeled with incorrect lot numbers. The cartons contain the correct lot number 200906 but vials inside are labeled with lot number 200901.

    Product
    THIAMINE HYDROCHLORIDE — THIAMINE HYDROCHLORIDE (THIAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1576-2020·2020-09-09

    Mylan Recalls Tranexamic Acid Injection Due to Labeling Mix-Up

    Mylan Institutional LLC is recalling 1,407 cartons of Tranexamic Acid Injection due to a labeling error that may result in the wrong medication being dispensed.

    Product
    TRANEXAMIC ACID — TRANEXAMIC ACID (TRANEXAMIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1575-2020·2020-09-09

    Mylan Recalls Amiodarone Hydrochloride Injection Due to Labeling Mix-Up

    Mylan Institutional LLC is recalling Amiodarone Hydrochloride Injection due to a labeling error where cartons may contain the wrong medication.

    Product
    AMIODARONE HYDROCHLORIDE — AMIODARONE HYDROCHLORIDE (AMIODARONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1484-2020·2020-08-12

    Mylan Recalls Daptomycin Injection Due to Particulate Matter

    Mylan Institutional LLC is recalling 18,480 vials of Daptomycin for Injection due to the presence of particulate matter. The product is distributed nationwide.

    Product
    DAPTOMYCIN — DAPTOMYCIN (DAPTOMYCIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1271-2020·2020-05-27

    Mylan Recalls Aloprim Injection Vials Due to Discoloration

    Mylan Institutional LLC is recalling 3,010 vials of Aloprim (allopurinol sodium) for Injection due to out-of-specification appearance and color results.

    Product
    ALOPRIM — ALOPRIM (ALLOPURINOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1333-2015·2015-08-26

    Mylan Recalls Gemcitabine Injection Vials Due to Particulate Matter

    Mylan Institutional LLC is recalling 2,455 vials of Gemcitabine for Injection due to the presence of particulate matter.

    Product
    Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-463-02, UPC 3 67457 46302 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1332-2015·2015-08-26

    Mylan Recalls Gemcitabine Injection Vials Due to Particulate Matter

    Mylan Institutional LLC is recalling specific lots of Gemcitabine for Injection due to the presence of particulate matter. The affected vials were distributed nationwide and in Puerto Rico.

    Product
    Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only, labeled as a) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-464-20, UPC 3 67457 46420 6; and b) Distributed by Pfizer Labs, Division of Pfize
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1334-2015·2015-08-26

    Mylan Recalls Gemcitabine for Injection Due to Particulate Matter

    Mylan Institutional LLC is recalling 10,094 vials of Gemcitabine for Injection due to the presence of particulate matter.

    Product
    Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-462-01, UPC 3 67457 46201 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1331-2015·2015-08-26

    Mylan Recalls Carboplatin Injection Due to Particulate Matter

    Mylan Institutional LLC is recalling Carboplatin Injection 450 mg/45 mL due to the presence of particulate matter.

    Product
    CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Multi-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-493-46, UPC 3 67457 49346 6.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1328-2015·2015-08-19

    Methotrexate Injection Recalled Due to Presence of Particulate Matter

    Mylan Institutional LLC is recalling Methotrexate Injection vials due to the presence of particulate matter.

    Product
    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, Ro
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1329-2015·2015-08-19

    Mylan Recalls Cytarabine Injection Vials Due to Particulate Matter

    Mylan Institutional LLC is recalling 8,340 vials of Cytarabine Injection due to the presence of particulate matter. The affected product was distributed nationwide.

    Product
    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 carton (NDC 0069-0152-02), Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0421-2015·2015-04-01

    Mylan Recalls Haloperidol Decanoate Vials Due to Sterility Concerns

    Mylan Institutional LLC is recalling specific lots of Haloperidol Decanoate Injection due to leaking vials that compromise sterility assurance.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0422-2015·2015-04-01

    Mylan Recalls Haloperidol Decanoate Injection Due to Sterility Concerns

    Mylan Institutional LLC is recalling Haloperidol Decanoate Injection because leaking vials raised concerns about the product's sterility.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0413-2015·2015-03-25

    Mylan Recalls Subpotent Nicardipine Hydrochloride Injection Vials

    Mylan Institutional LLC is recalling specific lots of Nicardipine Hydrochloride Injection because the product failed potency and impurity specifications.

    Product
    Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-224-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0412-2015·2015-03-25

    Mylan Recalls Doxorubicin Vials Due to Potential Mispackaging

    Mylan Institutional LLC is recalling 936 vials of Doxorubicin Hydrochloride Injection because they may have been mispackaged with Ifosfamide Injection.

    Product
    DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use Only, Sterile, ISOTONIC SOLUTION, Caution: Cytotoxic Agent, 100 mL Multi-Dose Vial, Rx Only, Manufactured By: Onco Therapies Limited, Bangalore, 560105, INDIA, Distributed By: Amneal-Agila, LLC, Glasgow
    Category
    Drug
    Distribution
    Distributed nationwide