Endo USA, Inc.

10 FDA enforcement actions

10 Total Recalls

5 Class I

0 Class II

5 Class III

Firm Details

Product Types: drug
States: PA, MI

All Recalls

Class III: Low Risk 10/10/2025 drug

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Class III: Low Risk 10/10/2025 drug

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Class III: Low Risk 10/10/2025 drug

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Class III: Low Risk 10/10/2025 drug

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Class III: Low Risk 09/05/2025 drug

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Class I: Dangerous 12/20/2024 drug

Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Class I: Dangerous 11/18/2024 drug

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Class I: Dangerous 11/18/2024 drug

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Class I: Dangerous 11/18/2024 drug

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Class I: Dangerous 11/18/2024 drug

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.