Amerisource Health Services LLC

42 FDA enforcement actions

42 Total Recalls

1 Class I

37 Class II

4 Class III

Firm Details

Product Types: drug
States: OH

All Recalls

Class II: Risk 10/16/2025 drug

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Class II: Risk 10/16/2025 drug

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Class II: Risk 10/16/2025 drug

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Class II: Risk 10/09/2025 drug

CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Class II: Risk 09/15/2025 drug

Failed Dissolution Specifications.
Class II: Risk 08/27/2025 drug

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II: Risk 08/27/2025 drug

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II: Risk 08/27/2025 drug

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II: Risk 08/27/2025 drug

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II: Risk 07/29/2025 drug

CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Class II: Risk 05/15/2025 drug

cGMP deviations
Class II: Risk 04/02/2025 drug

Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class II: Risk 04/02/2025 drug

Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class II: Risk 04/02/2025 drug

Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class II: Risk 03/24/2025 drug

cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
Class II: Risk 01/07/2025 drug

Presence of Foreign Tablets/Capsules
Class II: Risk 12/17/2024 drug

Failed Dissolution Specifications:
Class II: Risk 12/13/2024 drug

Presence of Foreign Tablets/Capsules
Class II: Risk 12/06/2024 drug

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Class II: Risk 12/06/2024 drug

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Class II: Risk 12/06/2024 drug

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Class II: Risk 12/06/2024 drug

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Class II: Risk 11/14/2024 drug

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Class II: Risk 11/14/2024 drug

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Class II: Risk 11/14/2024 drug

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Class I: Dangerous 06/25/2024 drug

Failed Dissolution Specifications
Class II: Risk 06/24/2024 drug

Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Class III: Low Risk 02/01/2024 drug

Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
Class II: Risk 01/25/2024 drug

CGMP Deviations
Class II: Risk 01/11/2024 drug

Failed Impurities/Degradation Specification.
Class III: Low Risk 12/26/2023 drug

Superpotent drug: Assay results were slightly above specification at the time zero point.
Class III: Low Risk 09/01/2023 drug

Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
Class II: Risk 06/23/2023 drug

Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
Class II: Risk 03/17/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 03/17/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 03/17/2023 drug

CGMP Deviations: recalling drug products following an FDA inspection.
Class II: Risk 03/16/2023 drug

Failed Dissolution Specifications: Out of specification dissolution results above specified values.
Class II: Risk 01/27/2023 drug

Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
Class II: Risk 01/11/2023 drug

Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.
Class II: Risk 12/27/2022 drug

Failed Impurities/Degradation Specifications
Class II: Risk 12/20/2022 drug

Failed Impurities/Degradations Specifications
Class III: Low Risk 07/27/2022 drug

Subpotent Drug

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.