The Recall Desk

Manufacturer

ENDO USA, Inc.

11 recalls in our database name ENDO USA, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
11
Critical
1
Severe
4
Most recent
2026-05-20

Of the 11 recalls from ENDO USA, Inc. we have scored against our rubric, 1 (9%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (36%) 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.

1–11 of 11

  • ModerateFDA (Drugs)·D-0527-2026·2026-05-20

    Buprenorphine Hydrochloride Injection Recall Due to Particulate Matter

    Endo USA, Inc. is recalling Buprenorphine Hydrochloride injection vials distributed nationwide due to the presence of particulate matter identified as Buprenorphine free base. The FDA classified this as a Class II recall.

    Product
    BUPRENORPHINE HYDROCHLORIDE — BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0142-2026·2025-11-05

    Everolimus 2.5 mg tablets recalled after an out of specification impurity result

    Endo USA is recalling 2,035 cartons of Everolimus tablets 2.5 mg after results came back out of specification for impurity IP-C.

    Product
    Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-119-91
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0140-2026·2025-11-05

    Everolimus 7.5 mg tablets recalled after an out of specification impurity result

    Endo USA is recalling 1,866 cartons of Everolimus tablets 7.5 mg after results came back out of specification for impurity IP-C.

    Product
    Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-127-91
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0139-2026·2025-11-05

    Everolimus tablets recalled after an out of specification impurity result

    Endo USA is recalling 6,655 cartons of Everolimus tablets 5 mg after results came back out of specification for impurity IP-C.

    Product
    Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-125-91
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0141-2026·2025-11-05

    Everolimus 10 mg tablets recalled after an out of specification impurity result

    Endo USA is recalling 935 cartons of Everolimus tablets 10 mg after results came back out of specification for impurity IP-C.

    Product
    Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-128-91
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0026-2026·2025-10-22

    Everolimus tablets recalled for out of specification impurity in one lot

    Endo USA is recalling 1,041 cartons of Everolimus tablets 5mg after the lot returned an out-of-specification result for impurity IP-C.

    Product
    Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 49884-125-91
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0223-2025·2025-02-12

    Adrenalin Chloride Epinephrine Nasal Solution Recalled for Misleading Label

    Par Pharmaceutical is recalling Adrenalin Chloride Solution (Epinephrine Nasal Solution) due to a misleading label that resembles the FDA-approved Adrenalin epinephrine injection product, creating potential confusion.

    Product
    Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-103-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0181-2025·2025-01-15

    Clonazepam Tablets Recalled Due to Carton Labeling Error

    Endo USA, Inc. is recalling 22,513 cartons of clonazepam tablets due to incorrect strength labeling on some carton exteriors. The actual tablets inside have correct labeling.

    Product
    CLONAZEPAM — CLONAZEPAM (CLONAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0178-2025·2025-01-15

    Clonazepam tablets recalled for incorrect carton labeling

    Endo USA is recalling approximately 9,816 cartons of Clonazepam 2 mg tablets due to incorrect strength labeling on the carton exterior. The blister strips inside contain the correct formulation.

    Product
    CLONAZEPAM — CLONAZEPAM (CLONAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0180-2025·2025-01-15

    Clonazepam Tablets Recalled Due to Incorrect Carton Labeling

    Endo USA recalls clonazepam tablets because some cartons are labeled with incorrect declared strength. The medication inside the blister strips contains the correct strength.

    Product
    CLONAZEPAM — CLONAZEPAM (CLONAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide