Cardinal Health Recalls Edarbyclor Tablets Due to Temperature Excursions
Cardinal Health Inc. is recalling 273 bottles of Edarbyclor tablets due to intermittent exposure to temperature excursions during storage.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a CGMP deviation (temperature excursion) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cardinal Health Inc. is recalling 273 bottles of Edarbyclor (azilsartan kamedoxomil and chlorthalidone) tablets. The product is a prescription medication manufactured for Arbor Pharmaceuticals. The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.
The affected product is identified by code 79551. The recall covers distribution in Florida, Georgia, and South Carolina. The source text does not specify the exact lot numbers or expiration dates for the affected units.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- EDARBYCLOR (AZILSARTAN KAMEDOXOMIL AND CHLORTHALIDONE)
- Brand
- EDARBYCLOR
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 273
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 79551
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 198 products in this recall →Related recalls
Same brand · EDARBYCLOR
- ModerateCardinal Health Recalls Edarbyclor Tablets Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
Same manufacturer · Cardinal Health Inc.
See all →- HighEnoxaparin syringe bags recalled after being labeled with the wrong strength
FDA (Drugs) · 2025-09-03
- ModerateXolair auto-injectors exposed to temperatures outside labeled storage requirements
FDA (Drugs) · 2025-08-13
- ModerateRecombinate antihemophilic factor vials exposed to temperatures outside labeled storage
FDA (Drugs) · 2025-08-13
- ModerateXolair 75 mg syringes exposed to temperatures outside labeled storage requirements
FDA (Drugs) · 2025-08-13
- ModerateWegovy injection recalled due to temperature exposure during shipping
FDA (Drugs) · 2025-05-07
Same hazard · temperature excursion
See all →- ModerateCyclophosphamide injection vials recalled after a transportation temperature excursion
FDA (Drugs) · 2025-09-24
- ModerateProlia prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateBenlysta vials recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateEvenity prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30