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Amerisource Health Services LLC FDA Recalls
46 recalls on file across drugs, 1 of them Class I and 30 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American HeClass IIIMay 1, 2026Cross contamination with other products: API contaminated wi |
| Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American HeaClass IIIMay 1, 2026Cross contamination with other products: API contaminated wi |
| Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NClass IIMar 16, 2026Failed tablet specifications. |
| Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug prodClass IIJan 14, 2026Defective container: card seal defects (weak/non-existent se |
| Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health PackaClass IIOct 16, 2025Failed Impurities/Degradation Specification: presence of N-n |
| Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Health PackaginClass IIOct 16, 2025Failed Impurities/Degradation Specification: presence of N-n |
| Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health PackaClass IIOct 16, 2025Failed Impurities/Degradation Specification: presence of N-n |
| Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, OhioClass IIOct 9, 2025CGMP Deviations: The recalling firm filed for Chapter 11 on |
| Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American HealClass IISep 15, 2025Failed Dissolution Specifications. |
| chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, Rx Only, Distributed by: American Health PacClass IIAug 27, 2025Presence of a foreign substance.A specific lot of auxiliary |
| chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: AmericanClass IIAug 27, 2025Presence of a foreign substance.A specific lot of auxiliary |
| chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: AmericanClass IIAug 27, 2025Presence of a foreign substance.A specific lot of auxiliary |
| chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (Individual Class IIAug 27, 2025Presence of a foreign substance.A specific lot of auxiliary |
| Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, OhioClass IIJul 29, 2025CGMP Deviations: The recalling firm filed for Chapter 11 in |
| Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed Class IIMay 15, 2025cGMP deviations |
| Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics LimiteClass IIApr 2, 2025Lack of assurance of sterility. Bacterial contamination dete |
| Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset TherapeuticsClass IIApr 2, 2025Lack of assurance of sterility. Bacterial contamination dete |
| Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset TherapeuticsClass IIApr 2, 2025Lack of assurance of sterility. Bacterial contamination dete |
| Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 individual blistered doses (30 Unit Dose perClass IIMar 24, 2025cGMP Deviations: Received notification from their supplier r |
| Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLClass IIJan 7, 2025Presence of Foreign Tablets/Capsules |
| glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American HeaClass IIDec 17, 2024Failed Dissolution Specifications: |
| Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLClass IIDec 13, 2024Presence of Foreign Tablets/Capsules |
| Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, HyClass IIDec 6, 2024CGMP Deviations: Presence of N-nitroso-duloxetine impurity a |
| Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, HyClass IIDec 6, 2024CGMP Deviations: Presence of N-nitroso-duloxetine impurity a |
| Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, HClass IIDec 6, 2024CGMP Deviations: Presence of N-nitroso-duloxetine impurity a |
| Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma LimitedClass IIDec 6, 2024CGMP Deviations: Presence of N-nitroso-duloxetine impurity a |
| Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-4Class IINov 14, 2024CGMP Deviations: Presence of N-nitroso-duloxetine impurity a |
| Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited,Class IINov 14, 2024CGMP Deviations: Presence of N-nitroso-duloxetine impurity a |
| Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, HClass IINov 14, 2024CGMP Deviations: Presence of N-nitroso-duloxetine impurity a |
| Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-coClass IJun 25, 2024Failed Dissolution Specifications |
| buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only,Class IIJun 24, 2024Failed Dissolution Specifications; the product is dissolving |
| HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: AmericClass IIIFeb 1, 2024Failed Impurities/Degradation Specifications: Out of Specifi |
| Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus,Class IIJan 25, 2024CGMP Deviations |
| Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx Only, Distributed by: American Health PackClass IIJan 11, 2024Failed Impurities/Degradation Specification. |
| Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American HeClass IIIDec 26, 2023Superpotent drug: Assay results were slightly above specific |
| HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American HealtClass IIISep 1, 2023Failed Impurities/Degradation Specifications: Out of Specifi |
| Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and DClass IIJun 23, 2023Failed Dissolution Specifications: this repackaged product w |
| Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-Class IIMar 17, 2023CGMP Deviations: recalling drug products following an FDA in |
| Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00; b) 500-count bottle; NDC# 6800Class IIMar 17, 2023CGMP Deviations: recalling drug products following an FDA in |
| Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00; b) 500-count bottle, NDC# 68001-1Class IIMar 17, 2023CGMP Deviations: recalling drug products following an FDA in |
| Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, 100 Tablets (10 x 10) per carton, Rx only, Distributed byClass IIMar 16, 2023Failed Dissolution Specifications: Out of specification diss |
| Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed byClass IIJan 27, 2023Failed Dissolution Specification: Out of specification disso |
| Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count bottle, NDC 68001-501-00; (b) 500-cClass IIJan 11, 2023Failed Dissolution Specifications: This recall is being init |
| BuPROPion Hydrochloride Tablets, USP 75 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health PClass IIDec 27, 2022Failed Impurities/Degradation Specifications |
| Rifampin Capsules USP, 300 mg, 100 Capsules (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, CoClass IIDec 20, 2022Failed Impurities/Degradations Specifications |
| Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas PharmaceuticalClass IIIJul 27, 2022Subpotent Drug |