ENDO USA Recalls
11 recalls on record · January 15, 2025 to May 20, 2026 · Drugs
Recalls by year
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 20, 2026DrugsFDA
ENDO USA, Inc. recalls Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern
Hazard: Crystallization; identified as Buprenorphine free base
November 5, 2025DrugsFDA
Endo USA, Inc. recalls Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured
Hazard: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
November 5, 2025DrugsFDA
Endo USA, Inc. recalls Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured
Hazard: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
November 5, 2025DrugsFDA
Endo USA, Inc. recalls Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured
Hazard: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
November 5, 2025DrugsFDA
Endo USA, Inc. recalls Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by
Hazard: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
October 22, 2025DrugsFDA
Endo USA, Inc. recalls Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by
Hazard: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
February 12, 2025DrugsFDA
ENDO USA, Inc. recalls Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed
Hazard: Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
January 15, 2025DrugsFDA
Endo USA, Inc. recalls Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6
Hazard: Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
January 15, 2025DrugsFDA
Endo USA, Inc. recalls Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containin
Hazard: Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
January 15, 2025DrugsFDA
Endo USA, Inc. recalls Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containi
Hazard: Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
January 15, 2025DrugsFDA
Endo USA, Inc. recalls Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6
Hazard: Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.