Amerisource Health Services LLC Recalls Recalls by year
A bar chart of the number of recalls naming this company by year.
Recalls by year
Year Recalls 2022 1 2023 10 2024 9 2025 22 2026 4
Download CSV FDA Recall
Ongoing
Historical record Class II
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05 by Amerisource Health Services LLC
Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. Published
January 1, 2025 Distribution
Nationwide
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FDA Recall
Ongoing
Historical record Class II
Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04 by Amerisource Health Services LLC
Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. Published
January 1, 2025 Distribution
Nationwide
View recall →
FDA Recall
Ongoing
Historical record Class II
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08 by Amerisource Health Services LLC
Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit Published
December 11, 2024 Distribution
Multiple states
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FDA Recall
Ongoing
Historical record Class II
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories by Amerisource Health Services LLC
Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit Published
December 11, 2024 Distribution
Multiple states
View recall →
FDA Recall
Ongoing
Historical record Class II
Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06 by Amerisource Health Services LLC
Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit Published
December 11, 2024 Distribution
Multiple states
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FDA Recall
Ongoing
Historical record Class I
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-count bottle (NDC 68001-396-03), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Distributed by: Dhar, Madhya Pradesh 454 775, India. Distributed for: BluePoint Laboratories. by Amerisource Health Services LLC
Reason
Failed Dissolution Specifications Published
August 7, 2024 Distribution
Nationwide
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FDA Recall
Ongoing
Historical record Class II
buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 60687-782-01. by Amerisource Health Services LLC
Reason
Failed Dissolution Specifications; the product is dissolving faster than the specified limits. Published
July 17, 2024 Distribution
Nationwide
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FDA Recall
Ongoing
Historical record Class III
HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-447-01; NDC Unit Dose: 68084-447-11 by Amerisource Health Services LLC
Reason
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point. Published
February 14, 2024 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-538-21, NDC Unit dose 60687-538-11 by Amerisource Health Services LLC
Reason
CGMP Deviations Published
February 14, 2024 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-575-21; NDC Unit Dose: 60687-575-11 by Amerisource Health Services LLC
Reason
Failed Impurities/Degradation Specification. Published
February 7, 2024 Distribution
Nationwide
View recall →
FDA Recall
Ongoing
Historical record Class III
Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC 68084-214-01; Individual Dose NDC 68084-214-11 by Amerisource Health Services LLC
Reason
Superpotent drug: Assay results were slightly above specification at the time zero point. Published
January 31, 2024 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class III
HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 68084-447-01; Individual Dose NDC: 68084-447-11 by Amerisource Health Services LLC
Reason
Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point. Published
October 11, 2023 Distribution
Nationwide
View recall →
This page lists recalls that name Amerisource Health Services LLC as the recalling firm in the official source notice. It is
not a safety rating, ranking, or statement that the company acted negligently.
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