Cardinal Health Recalls Darifenacin Tablets Due to Temperature Excursions
Cardinal Health Inc. is recalling 52 bottles of Darifenacin Extended-release Tablets 7.5 mg due to intermittent 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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a manufacturing deviation (temperature excursion) without reported injuries, fitting the Moderate category for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Cardinal Health Inc. is recalling 52 bottles of Darifenacin Extended-release Tablets 7.5 mg, 30-count bottles. The product is a prescription-only medication manufactured by Torrent Pharmaceuticals Ltd. in India for Torrent Pharma Inc. in New Jersey. The recall is limited to specific stock identified by the code BDZ7G005.
The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage. This condition may affect the stability and quality of the medication.
The affected product was distributed in Florida, Georgia, and South Carolina. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or refund.
The recalled product
- Product
- DARIFENACIN (DARIFENACIN)
- Brand
- DARIFENACIN
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 52
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)
- BDZ7G005
UPCs (2)
- 0313668202304
- 0313668203301
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 · DARIFENACIN
- ModerateCardinal Health Recalls Darifenacin 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