Amerisource Health Services recalls
Amerisource Health Services appears in 69 official U.S. recall notices indexed by RecallRadar, most recently on 2026-05-27.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 69 |
|---|---|
| Published | 2016-01-20 to 2026-05-27 |
| By agency | FDA Drug (69) |
| By classification | Class II (54), Class III (14), Class I (1) |
| By status | terminated (39), ongoing (30) |
| Distribution named in notices | OH, PA, PR, US |
Recalls
- Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Colu…
FDA Drug · Class III · 2026-05-27 · Amerisource Health Services
Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. - Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Col…
FDA Drug · Class III · 2026-05-27 · Amerisource Health Services
Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. - Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NDC 60687-775-11), R…
FDA Drug · Class II · 2026-04-01 · Amerisource Health Services
Reason: Failed tablet specifications. - Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in this…
FDA Drug · Class II · 2026-02-18 · Amerisource Health Services
Reason: Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities. - Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohi…
FDA Drug · Class II · 2025-11-05 · Amerisource Health Services
Reason: Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit - Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohi…
FDA Drug · Class II · 2025-11-05 · Amerisource Health Services
Reason: Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit - Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 4…
FDA Drug · Class II · 2025-11-05 · Amerisource Health Services
Reason: Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit - Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-6…
FDA Drug · Class II · 2025-10-22 · Amerisource Health Services
Reason: 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 c… - Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Colum…
FDA Drug · Class II · 2025-10-08 · Amerisource Health Services
Reason: Failed Dissolution Specifications. - chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging,…
FDA Drug · Class II · 2025-09-24 · Amerisource Health Services
Reason: 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 tabl… - chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, Rx Only, Distributed by: American Health Packaging, Columbus, O…
FDA Drug · Class II · 2025-09-24 · Amerisource Health Services
Reason: 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 tabl… - chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging,…
FDA Drug · Class II · 2025-09-24 · Amerisource Health Services
Reason: 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 tabl… - chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65
FDA Drug · Class II · 2025-09-24 · Amerisource Health Services
Reason: 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 tabl… - Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC 60687-69…
FDA Drug · Class II · 2025-09-03 · Amerisource Health Services
Reason: 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 chara… - Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Health…
FDA Drug · Class II · 2025-06-11 · Amerisource Health Services
Reason: cGMP deviations - Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal…
FDA Drug · Class II · 2025-04-30 · Amerisource Health Services
Reason: Lack of assurance of sterility. Bacterial contamination detected in some media fill units - Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Bood…
FDA Drug · Class II · 2025-04-30 · Amerisource Health Services
Reason: Lack of assurance of sterility. Bacterial contamination detected in some media fill units - Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boo…
FDA Drug · Class II · 2025-04-30 · Amerisource Health Services
Reason: Lack of assurance of sterility. Bacterial contamination detected in some media fill units - Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 individual blistered doses (30 Unit Dose per carton), Rx only,…
FDA Drug · Class II · 2025-04-09 · Amerisource Health Services
Reason: cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product. - glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Colu…
FDA Drug · Class II · 2025-01-22 · Amerisource Health Services
Reason: Failed Dissolution Specifications: - Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by:…
FDA Drug · Class II · 2025-01-22 · Amerisource Health Services
Reason: Presence of Foreign Tablets/Capsules - Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by:…
FDA Drug · Class II · 2025-01-15 · Amerisource Health Services
Reason: Presence of Foreign Tablets/Capsules - Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, In…
FDA Drug · Class II · 2025-01-01 · Amerisource Health Services
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. - Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090…
FDA Drug · Class II · 2025-01-01 · Amerisource Health Services
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. - Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, I…
FDA Drug · Class II · 2025-01-01 · Amerisource Health Services
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. - Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, In…
FDA Drug · Class II · 2025-01-01 · Amerisource Health Services
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. - 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, Man…
FDA Drug · Class II · 2024-12-11 · Amerisource Health Services
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit - Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090,…
FDA Drug · Class II · 2024-12-11 · Amerisource Health Services
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit - Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, I…
FDA Drug · Class II · 2024-12-11 · Amerisource Health Services
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit - Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-count bottle (NDC 680…
FDA Drug · Class I · 2024-08-07 · Amerisource Health Services
Reason: Failed Dissolution Specifications - buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: Am…
FDA Drug · Class II · 2024-07-17 · Amerisource Health Services
Reason: Failed Dissolution Specifications; the product is dissolving faster than the specified limits. - HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging…
FDA Drug · Class III · 2024-02-14 · Amerisource Health Services
Reason: Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point. - Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217
FDA Drug · Class II · 2024-02-14 · Amerisource Health Services
Reason: CGMP Deviations - Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Oh…
FDA Drug · Class II · 2024-02-07 · Amerisource Health Services
Reason: Failed Impurities/Degradation Specification. - Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Col…
FDA Drug · Class III · 2024-01-31 · Amerisource Health Services
Reason: Superpotent drug: Assay results were slightly above specification at the time zero point. - HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columb…
FDA Drug · Class III · 2023-10-11 · Amerisource Health Services
Reason: Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point. - Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and Distributed by: Amer…
FDA Drug · Class II · 2023-07-12 · Amerisource Health Services
Reason: Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution. - Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00
FDA Drug · Class II · 2023-05-31 · Amerisource Health Services
Reason: CGMP Deviations: recalling drug products following an FDA inspection. - Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00
FDA Drug · Class II · 2023-05-31 · Amerisource Health Services
Reason: CGMP Deviations: recalling drug products following an FDA inspection. - Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00
FDA Drug · Class II · 2023-05-31 · Amerisource Health Services
Reason: CGMP Deviations: recalling drug products following an FDA inspection. - Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, 100 Tablets (10 x 10) per carton, Rx only, Distributed by: American Health P…
FDA Drug · Class II · 2023-04-26 · Amerisource Health Services
Reason: Failed Dissolution Specifications: Out of specification dissolution results above specified values. - Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by: American Health P…
FDA Drug · Class II · 2023-03-15 · Amerisource Health Services
Reason: Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values. - BuPROPion Hydrochloride Tablets, USP 75 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus,…
FDA Drug · Class II · 2023-02-22 · Amerisource Health Services
Reason: Failed Impurities/Degradation Specifications - Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count bottle, NDC 68001-501-00
FDA Drug · Class II · 2023-02-22 · Amerisource Health Services
Reason: Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories. - Rifampin Capsules USP, 300 mg, 100 Capsules (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217,…
FDA Drug · Class II · 2023-01-25 · Amerisource Health Services
Reason: Failed Impurities/Degradations Specifications - Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez,…
FDA Drug · Class III · 2022-08-24 · Amerisource Health Services
Reason: Subpotent Drug - Paroxetine Tablets, USP, 30mg, 100 tablets (10 x 10) , Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217
FDA Drug · Class II · 2017-11-29 · Amerisource Health Services
Reason: Presence of Foreign Tablets/Capsules. - Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only
FDA Drug · Class III · 2017-11-22 · Amerisource Health Services
Reason: Failed Stability Specifications - GlipiZIDE Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21), Individual dose (NDC 68084-395-11), Rx Only, Packaged and D…
FDA Drug · Class II · 2017-03-22 · Amerisource Health Services
Reason: Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point. - CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed by American Health Packaging, Columbus, OH--- NDC…
FDA Drug · Class II · 2017-03-08 · Amerisource Health Services
Reason: Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities