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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

Past Year

Class I (Serious)

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 21–28 of 28 recalls

Duloxetine Capsules 60mg (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 60 mg (Amerisource) – Impurity Concern (2024)

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

Class IIModerate

FDANov 14, 2024OH, PA, PR• Amerisource Health Services LLC

Duloxetine Capsules (Amerisource) – Impurity Limit Exceeded (2024)

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

Page 2 of 2Next

Class II

Moderate

FDANov 14, 2024OH, PA, PR• Amerisource Health Services LLC

Duloxetine Capsules 30 mg (Amerisource) – Impurity Concern (2024)

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

Class IIModerate

FDANov 14, 2024OH, PA, PR• Amerisource Health Services LLC

Potassium Chloride Capsules (Amerisource) – Dissolution Failure (2024)

Failed Dissolution Specifications

Class IHigh

FDAJun 25, 2024Nationwide• Amerisource Health Services LLC

Bupropion Extended-Release Tablets (Amerisource) – Dissolution Issue (2024)

Failed Dissolution Specifications; the product is dissolving faster than the specified limits.

Class IIModerate

FDAJun 24, 2024Nationwide• Amerisource Health Services LLC

HydrALAZINE Tablets (Amerisource) – Impurities Specification (2024)

Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.

Class IIILow

FDAFeb 1, 2024Nationwide• Amerisource Health Services LLC

Benzonatate Capsules (Amerisource) – Superpotent Drug (2023)

Superpotent drug: Assay results were slightly above specification at the time zero point.

Class IIILow

FDADec 26, 2023Nationwide• Amerisource Health Services LLC