Recall Record

Columbus, OH, United States

Amerisource Health Services LLC recalls

31 recalls recorded since 2018, most recently on 1 May 2026. 17 are listed as ongoing. Status and classification are as published by the FDA.

Recalls31
Ongoing (FDA)17
Terminated or completed14
Class I (FDA)1

Ongoing Class III Drugs

Recall started
1 May 2026
Reason
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Distribution
USA Nationwide
Initiated
Voluntary: Firm initiated
Recall numbers
D-0537-2026, D-0536-2026

Ongoing Class II Drugs

Recall started
16 March 2026
Reason
Failed tablet specifications.
Distribution
U.S. Nationwide
Initiated
Voluntary: Firm initiated
Recall number
D-0418-2026

Ongoing Class II Drugs

Recall started
14 January 2026
Reason
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Distribution
Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall number
D-0338-2026

Ongoing Class II Drugs

Recall started
16 October 2025
Reason
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Distribution
Nationwide within the United States
Initiated
Voluntary: Firm initiated
Recall numbers
D-0103-2026, D-0102-2026, D-0101-2026

Ongoing Class II Drugs

Recall started
9 October 2025
Reason
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.
Distribution
Nationwide within the United States
Initiated
Voluntary: Firm initiated
Recall number
D-0027-2026

Ongoing Class II Drugs

Recall started
15 September 2025
Reason
Failed Dissolution Specifications.
Distribution
Nationwide in the USA.
Initiated
Voluntary: Firm initiated
Recall number
D-0675-2025

Ongoing Class II Drugs

Recall started
27 August 2025
Reason
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.
Distribution
Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall numbers
D-0650-2025, D-0648-2025, D-0649-2025, D-0647-2025

Ongoing Class II Drugs

Recall started
29 July 2025
Reason
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.
Distribution
Nationwide
Initiated
Voluntary: Firm initiated
Recall number
D-0598-2025

Ongoing Class II Drugs

Recall started
15 May 2025
Reason
cGMP deviations
Distribution
Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall number
D-0454-2025

Ongoing Class II Drugs

Recall started
2 April 2025
Reason
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Distribution
Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall numbers
D-0368-2025, D-0369-2025, D-0367-2025

Terminated Class II Drugs

Recall started
24 March 2025
Terminated
10 February 2026
Reason
cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
Distribution
USA nationwide.
Initiated
Voluntary: Firm initiated
Recall number
D-0307-2025

Ongoing Class II Drugs

Recall started
7 January 2025
Reason
Presence of Foreign Tablets/Capsules
Distribution
Nationwide within the United States
Initiated
Voluntary: Firm initiated
Recall number
D-0201-2025

Terminated Class II Drugs

Recall started
17 December 2024
Terminated
16 April 2026
Reason
Failed Dissolution Specifications:
Distribution
Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall number
D-0202-2025

Ongoing Class II Drugs

Recall started
13 December 2024
Reason
Presence of Foreign Tablets/Capsules
Distribution
Nationwide within the United States
Initiated
Voluntary: Firm initiated
Recall number
D-0184-2025

Ongoing Class II Drugs

Recall started
6 December 2024
Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Distribution
Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall numbers
D-0156-2025, D-0155-2025, D-0157-2025, D-0158-2025

Ongoing Class II Drugs

Recall started
14 November 2024
Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Distribution
PA, OH, PR
Initiated
Voluntary: Firm initiated
Recall numbers
D-0101-2025, D-0100-2025, D-0099-2025

Ongoing Class I Drugs

Recall started
25 June 2024
Reason
Failed Dissolution Specifications
Distribution
US Nationwide.
Initiated
Voluntary: Firm initiated
Recall number
D-0619-2024

Ongoing Class II Drugs

Recall started
24 June 2024
Reason
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Distribution
Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall number
D-0590-2024

Terminated Class III Drugs

Recall started
1 February 2024
Terminated
1 September 2026
Reason
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
Distribution
Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall number
D-0320-2024

Terminated Class II Drugs

Recall started
25 January 2024
Terminated
22 December 2025
Reason
CGMP Deviations
Distribution
USA Nationwide
Initiated
Voluntary: Firm initiated
Recall number
D-0314-2024

Terminated Class II Drugs

Recall started
11 January 2024
Terminated
30 September 2024
Reason
Failed Impurities/Degradation Specification.
Distribution
Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall number
D-0285-2024

Ongoing Class III Drugs

Recall started
26 December 2023
Reason
Superpotent drug: Assay results were slightly above specification at the time zero point.
Distribution
Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall number
D-0257-2024

Terminated Class III Drugs

Recall started
1 September 2023
Terminated
16 July 2024
Reason
Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
Distribution
Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall number
D-0039-2024

Terminated Class II Drugs

Recall started
23 June 2023
Terminated
6 September 2024
Reason
Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
Distribution
Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall number
D-0892-2023

Terminated Class II Drugs

Recall started
17 March 2023
Terminated
6 September 2024
Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Distribution
Nationwide USA
Initiated
Voluntary: Firm initiated
Recall numbers
D-0759-2023, D-0758-2023, D-0757-2023

Terminated Class II Drugs

Recall started
16 March 2023
Terminated
12 May 2024
Reason
Failed Dissolution Specifications: Out of specification dissolution results above specified values.
Distribution
Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall number
D-0536-2023

Terminated Class II Drugs

Recall started
27 January 2023
Terminated
12 May 2024
Reason
Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
Distribution
Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall number
D-0436-2023

Terminated Class II Drugs

Recall started
11 January 2023
Terminated
12 May 2024
Reason
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.
Distribution
Nationwide USA
Initiated
Voluntary: Firm initiated
Recall number
D-0269-2023

Terminated Class II Drugs

Recall started
27 December 2022
Terminated
4 August 2023
Reason
Failed Impurities/Degradation Specifications
Distribution
Nationwide within the USA
Initiated
Voluntary: Firm initiated
Recall number
D-0328-2023

Terminated Class II Drugs

Recall started
20 December 2022
Terminated
6 September 2024
Reason
Failed Impurities/Degradations Specifications
Distribution
Nationwide in the USA.
Initiated
Voluntary: Firm initiated
Recall number
D-0165-2023

Terminated Class III Drugs

Recall started
27 July 2022
Terminated
28 September 2023
Reason
Subpotent Drug
Distribution
Nationwide within the USA
Initiated
Voluntary: Firm initiated
Recall number
D-1349-2022

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.