Amerisource Health Services LLC
Complete recall history across all FDA and CPSC categories — 44 total recalls
Amerisource Health Services LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (44)
FDA drug safety enforcement actions by Amerisource Health Services LLC
| Date | Product | Reason | Class |
|---|---|---|---|
| May 1, 2026 | Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per c... | Cross contamination with other products: API contaminated with trace amounts ... | Class III |
| May 1, 2026 | Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per ca... | Cross contamination with other products: API contaminated with trace amounts ... | Class III |
| Mar 16, 2026 | Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60... | Failed tablet specifications. | Class II |
| Jan 14, 2026 | Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) bliste... | Defective container: Multiple customer complaints received for card seal defe... | Class II |
| Oct 16, 2025 | Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx... | Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin i... | Class II |
| Oct 16, 2025 | Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx... | Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin i... | Class II |
| Oct 16, 2025 | Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx on... | Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin i... | Class II |
| Oct 9, 2025 | Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by... | CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 202... | Class II |
| Sep 15, 2025 | Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x... | Failed Dissolution Specifications. | Class II |
| Aug 27, 2025 | chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) bl... | Presence of a foreign substance.A specific lot of auxiliary polyester coil, u... | Class II |
| Aug 27, 2025 | chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack pe... | Presence of a foreign substance.A specific lot of auxiliary polyester coil, u... | Class II |
| Aug 27, 2025 | chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, R... | Presence of a foreign substance.A specific lot of auxiliary polyester coil, u... | Class II |
| Aug 27, 2025 | chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack pe... | Presence of a foreign substance.A specific lot of auxiliary polyester coil, u... | Class II |
| Jul 29, 2025 | Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by... | CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. A... | Class II |
| May 15, 2025 | Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blist... | cGMP deviations | Class II |
| Apr 2, 2025 | Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, M... | Lack of assurance of sterility. Bacterial contamination detected in some medi... | Class II |
| Apr 2, 2025 | Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx On... | Lack of assurance of sterility. Bacterial contamination detected in some medi... | Class II |
| Apr 2, 2025 | Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx o... | Lack of assurance of sterility. Bacterial contamination detected in some medi... | Class II |
| Mar 24, 2025 | Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 i... | cGMP Deviations: Received notification from their supplier requesting they pe... | Class II |
| Jan 7, 2025 | Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister card... | Presence of Foreign Tablets/Capsules | Class II |
| Dec 17, 2024 | glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) ca... | Failed Dissolution Specifications: | Class II |
| Dec 13, 2024 | Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister card... | Presence of Foreign Tablets/Capsules | Class II |
| Dec 6, 2024 | Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommen... | Class II |
| Dec 6, 2024 | Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Ma... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommen... | Class II |
| Dec 6, 2024 | Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Ma... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommen... | Class II |
| Dec 6, 2024 | Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, M... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommen... | Class II |
| Nov 14, 2024 | Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, M... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommen... | Class II |
| Nov 14, 2024 | Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommen... | Class II |
| Nov 14, 2024 | Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle,... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommen... | Class II |
| Jun 25, 2024 | Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-... | Failed Dissolution Specifications | Class I |
| Jun 24, 2024 | buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg,... | Failed Dissolution Specifications; the product is dissolving faster than the ... | Class II |
| Feb 1, 2024 | HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit d... | Failed Impurities/Degradation Specifications: Out of Specification (OOS) resu... | Class III |
| Jan 25, 2024 | Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distribut... | CGMP Deviations | Class II |
| Jan 11, 2024 | Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx... | Failed Impurities/Degradation Specification. | Class II |
| Dec 26, 2023 | Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose c... | Superpotent drug: Assay results were slightly above specification at the time... | Class III |
| Sep 1, 2023 | HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per cart... | Failed Impurities/Degradation Specifications: Out of Specification results in... | Class III |
| Jun 23, 2023 | Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister... | Failed Dissolution Specifications: this repackaged product was recalled by th... | Class II |
| Mar 17, 2023 | Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 6800... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II |
| Mar 17, 2023 | Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 6... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II |
| Mar 17, 2023 | Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 680... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II |
| Mar 16, 2023 | Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, 100 Tablets (1... | Failed Dissolution Specifications: Out of specification dissolution results a... | Class II |
| Jan 27, 2023 | Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 T... | Failed Dissolution Specification: Out of specification dissolution results at... | Class II |
| Jan 11, 2023 | Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 10... | Failed Dissolution Specifications: This recall is being initiated in support ... | Class II |
| Dec 27, 2022 | BuPROPion Hydrochloride Tablets, USP 75 mg, 100 Tablets (10 x 10) per carton,... | Failed Impurities/Degradation Specifications | Class II |
| Dec 20, 2022 | Rifampin Capsules USP, 300 mg, 100 Capsules (10 x 10) per carton, Rx Only, Di... | Failed Impurities/Degradations Specifications | Class II |
| Jul 27, 2022 | Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx O... | Subpotent Drug | Class III |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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