Endo Pharmaceuticals, Inc.

2 FDA enforcement actions

2 Total Recalls

1 Class I

1 Class II

0 Class III

Firm Details

Product Types: drug
States: PA

All Recalls

Class I: Dangerous 07/10/2024 drug

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.
Class II: Risk 03/02/2023 drug

Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.

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.