Cardinal Health Recalls Bisoprolol Fumarate and Hydrochlorothiazide Tablets for Temperature Excursions
Cardinal Health Inc. is recalling 235 bottles of Bisoprolol Fumarate and Hydrochlorothiazide tablets due to intermittent exposure to temperature excursions during storage.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 and involves 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 235 bottles of Bisoprolol Fumarate and Hydrochlorothiazide tablets, 2.5 mg/6.25 mg, 100-count bottles. The product is distributed by Teva Pharmaceuticals USA, Inc., and is identified by NDC 0093-3241-01 and code 1417295A.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.
Consumers with this product should contact their healthcare provider or pharmacist for guidance on whether to discontinue use or obtain a replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE)
- Brand
- BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 235
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)
- 1417295A
UPCs (2)
- 0300933241014
- 0300933243568
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 · BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
- ModerateBisoprolol and hydrochlorothiazide tablets recalled over a nitrosamine impurity
FDA (Drugs) · 2026-02-11
- ModerateBisoprolol and hydrochlorothiazide tablets recalled over traces of another drug
FDA (Drugs) · 2025-12-10
- ModerateBisoprolol Fumarate and Hydrochlorothiazide Tablets Recalled for Failed Quality Specifications
FDA (Drugs) · 2023-11-08
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
Similar recalls
- HighFDA Recalls Lisinopril and Hydrochlorothiazide Tablets Due to Temperature Storage Deviations
FDA (Drugs) · 2024-01-03
- ModerateChlorthalidone Tablets Recalled for Temperature Storage Deviations
FDA (Drugs) · 2024-01-03
- HighDrug Recall: Hydralazine Hydrochloride Tablets Due to Improper Storage
FDA (Drugs) · 2024-01-03
- ModerateCitalopram Tablets Recalled for Temperature Storage Deviation
FDA (Drugs) · 2024-01-03
- ModerateBisoprolol Fumarate and Hydrochlorothiazide Tablets Recalled for Failed Quality Specifications
FDA (Drugs) · 2023-11-08
- HighDonepezil Hydrochloride Tablets Recalled Due to Storage Temperature Deviations
FDA (Drugs) · 2024-01-03