Heritage Pharmaceuticals Inc

8 FDA enforcement actions

8 Total Recalls

0 Class I

7 Class II

1 Class III

Firm Details

Product Types: drug
States: NJ

All Recalls

Class II: Risk 10/06/2025 drug

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II: Risk 10/06/2025 drug

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II: Risk 10/06/2025 drug

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II: Risk 10/06/2025 drug

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II: Risk 10/06/2025 drug

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II: Risk 10/06/2025 drug

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II: Risk 11/23/2022 drug

Subpotent Drug
Class III: Low Risk 04/21/2021 drug

Labeling: Incorrect or Missing Lot and/or Exp Date

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.