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Amerisource Health Services LLC

Amerisource Health Services LLC Recalls

All product recalls associated with Amerisource Health Services LLC.

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Recall Summary

Total Recalls

65

Past Year

15

Class I (Serious)

1

Most Recent

Oct 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 65 recalls

Prazosin Hydrochloride 1mg Capsules (Amerisource) – Impurity Risk (2025)

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

Class IIModerate

FDAOct 16, 2025Nationwide• Amerisource Health Services LLC

Prazosin Hydrochloride 2mg Capsules (Amerisource) – Impurity Risk (2025)

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

Class IIModerate

FDAOct 16, 2025Nationwide• Amerisource Health Services LLC

Prazosin Hydrochloride 5mg Capsules (Amerisource) – Impurity Risk (2025)

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Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

Class IIModerate

FDAOct 16, 2025Nationwide• Amerisource Health Services LLC

Sucralfate Tablets (Amerisource) – Quality Management (2025)

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 IIModerate

FDAOct 9, 2025Nationwide• Amerisource Health Services LLC

Carbamazepine Tablets (Amerisource) – Dissolution Issue (2025)

Failed Dissolution Specifications.

Class IIModerate

FDASep 15, 2025Nationwide• Amerisource Health Services LLC

Chlorpromazine Tablets (Amerisource) – Foreign Substance Detected (2025)

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 IIModerate

FDAAug 27, 2025Nationwide• Amerisource Health Services LLC

Chlorpromazine Tablets (Amerisource) – Foreign Substance Detected (2025)

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 IIModerate

FDAAug 27, 2025Nationwide• Amerisource Health Services LLC

Chlorpromazine Tablets (Amerisource) – Foreign substance packaging (2025)

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 IIModerate

FDAAug 27, 2025Nationwide• Amerisource Health Services LLC

Chlorpromazine Tablets (Amerisource) – Foreign substance packaging (2025)

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 IIModerate

FDAAug 27, 2025Nationwide• Amerisource Health Services LLC

Sucralfate Tablets (Amerisource) – Quality Monitoring Failure (2025)

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 IIModerate

FDAJul 29, 2025Nationwide• Amerisource Health Services LLC

Indomethacin Extended-Release Capsules (Amerisource) – Manufacturing Deviation (2025)

cGMP deviations

Class IIModerate

FDAMay 15, 2025Nationwide• Amerisource Health Services LLC

Haloperidol Decanoate Injection (Amerisource) – Sterility Risk (2025)

Lack of assurance of sterility. Bacterial contamination detected in some media fill units

Class IIModerate

FDAApr 2, 2025Nationwide• Amerisource Health Services LLC

Haloperidol Decanoate Injection (Amerisource) – Sterility Risk (2025)

Lack of assurance of sterility. Bacterial contamination detected in some media fill units

Class IIModerate

FDAApr 2, 2025Nationwide• Amerisource Health Services LLC

Haloperidol Decanoate Injection (Amerisource) – Sterility Risk (2025)

Lack of assurance of sterility. Bacterial contamination detected in some media fill units

Class IIModerate

FDAApr 2, 2025Nationwide• Amerisource Health Services LLC

Voriconazole Tablets (Amerisource) – Supplier Notification (2025)

cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.

Class IIModerate

FDAMar 24, 2025Nationwide• Amerisource Health Services LLC

Clobazam Tablets (Amerisource) – Foreign Tablets (2025)

Presence of Foreign Tablets/Capsules

Class IIModerate

FDAJan 7, 2025Nationwide• Amerisource Health Services LLC

GlipiZIDE Extended-Release Tablets (Amerisource) – Dissolution Failure (2024)

Failed Dissolution Specifications:

Class IIModerate

FDADec 17, 2024Nationwide• Amerisource Health Services LLC

Clobazam Tablets (Amerisource) – Foreign Tablet Contamination (2024)

Presence of Foreign Tablets/Capsules

Class IIModerate

FDADec 13, 2024Nationwide• Amerisource Health Services LLC

Duloxetine Capsules 30mg (Amerisource) – CGMP Impurity Limit (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.

Class IIModerate

FDADec 6, 2024Nationwide• Amerisource Health Services LLC

Duloxetine Capsules 30mg (Amerisource) – CGMP Impurity Limit (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.

Class IIModerate

FDADec 6, 2024Nationwide• Amerisource Health Services LLC