Akorn, Inc.

132 FDA enforcement actions

132 Total Recalls

0 Class I

127 Class II

5 Class III

Firm Details

Product Types: drug
States: IL

All Recalls

Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II: Risk 04/26/2023 drug

CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class III: Low Risk 01/30/2023 drug

Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Class II: Risk 10/13/2022 drug

CGMP Deviations:
Class II: Risk 10/13/2022 drug

CGMP Deviations:
Class II: Risk 10/13/2022 drug

CGMP Deviations:
Class II: Risk 10/13/2022 drug

CGMP Deviations:
Class II: Risk 10/13/2022 drug

CGMP Deviations:
Class II: Risk 10/13/2022 drug

CGMP Deviations:
Class II: Risk 10/13/2022 drug

CGMP Deviations:
Class II: Risk 10/13/2022 drug

CGMP Deviations:
Class II: Risk 10/13/2022 drug

CGMP Deviations:
Class II: Risk 10/13/2022 drug

CGMP Deviations:
Class II: Risk 10/13/2022 drug

CGMP Deviations:
Class II: Risk 10/13/2022 drug

CGMP Deviations:
Class II: Risk 10/13/2022 drug

CGMP Deviations:
Class II: Risk 10/13/2022 drug

CGMP Deviations:
Class II: Risk 10/13/2022 drug

CGMP Deviations:
Class II: Risk 10/13/2022 drug

CGMP Deviations:
Class II: Risk 10/13/2022 drug

CGMP Deviations:
Class II: Risk 10/13/2022 drug

CGMP Deviations:
Class II: Risk 10/13/2022 drug

CGMP Deviations:
Class II: Risk 10/13/2022 drug

CGMP Deviations:
Class II: Risk 10/13/2022 drug

CGMP Deviations:
Class II: Risk 10/13/2022 drug

CGMP Deviations:
Class II: Risk 10/13/2022 drug

CGMP Deviations:
Class II: Risk 10/13/2022 drug

CGMP Deviations:
Class II: Risk 10/13/2022 drug

CGMP Deviations:
Class II: Risk 10/13/2022 drug

CGMP Deviations:
Class II: Risk 10/13/2022 drug

CGMP Deviations:
Class II: Risk 09/21/2022 drug

Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Class II: Risk 09/21/2022 drug

Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Class II: Risk 08/31/2022 drug

cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Class II: Risk 08/31/2022 drug

cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Class III: Low Risk 08/08/2022 drug

Identification of an unknown impurity at the 12-month stability point. Further investigation has identified the impurity as Timolol Phenol S-Oxide.
Class II: Risk 08/01/2022 drug

Defective Container: Product has incomplete induction seals.
Class II: Risk 06/13/2022 drug

Defective container: defect prevents product from dispensing as intended.
Class II: Risk 06/10/2022 drug

Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.
Class III: Low Risk 04/15/2022 drug

Failed viscosity specification - product was below specificcation
Class II: Risk 01/05/2022 drug

Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Class III: Low Risk 12/03/2021 drug

Labeling: Missing Label
Class III: Low Risk 12/03/2021 drug

Labeling: Missing Label
Class II: Risk 10/04/2021 drug

Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
Class II: Risk 09/08/2021 drug

Lack of Assurance of Sterility
Class II: Risk 08/13/2021 drug

Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
Class II: Risk 08/02/2021 drug

Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the Bacillus cereus group.
Class II: Risk 03/08/2021 drug

Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Class II: Risk 12/28/2020 drug

Defective container: Customer complaints for oral solution leaking from bottles.

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.