Endo recalls
FDA enforcement reports naming Endo USA, Inc. as the recalling firm.
- Recall reports
- 11
- Class I (serious)
- 5
- Most recent report
- May 20, 2026
- May 20, 2026Buprenorphine Hydrochloride, Injection, 0Drug · ENDO USA, Inc.Crystallization; identified as Buprenorphine free baseClass II
- Nov 5, 2025Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablet…Drug · Endo USA, Inc.Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.Class III
- Nov 5, 2025Everolimus tablets 2Drug · Endo USA, Inc.Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.Class III
- Nov 5, 2025Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tabl…Drug · Endo USA, Inc.Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.Class III
- Nov 5, 2025Everolimus tablets 7Drug · Endo USA, Inc.Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.Class III
- Oct 22, 2025Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablet…Drug · Endo USA, Inc.Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.Class III
- Feb 12, 2025Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), pack…Drug · ENDO USA, Inc.Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)Class I
- Jan 15, 2025Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carto…Drug · Endo USA, Inc.Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.Class I
- Jan 15, 2025Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per cart…Drug · Endo USA, Inc.Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.Class I
- Jan 15, 2025Clonazepam Orally Disintegrating Tablets, USP, 0Drug · Endo USA, Inc.Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.Class I
- Clonazepam Orally Disintegrating Tablets, USP, 0
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