Cardinal Health Recalls Trazodone Hydrochloride Tablets Due to Temperature Excursions
Cardinal Health Inc. is recalling Trazodone Hydrochloride 50mg 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 the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cardinal Health Inc. is recalling 91 cartons of Trazodone Hydrochloride Tablets, USP 50mg (NDC 0904-6868-61). The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.
The affected product was distributed in Florida, Georgia, and South Carolina. The specific lot code for the recalled product is R01580.
Consumers and healthcare providers with this product should stop using it and contact their pharmacist or healthcare provider for guidance on replacement or disposal.
The recalled product
- Product
- TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE)
- Brand
- TRAZODONE HYDROCHLORIDE
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 91
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)
- R01580
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 · TRAZODONE HYDROCHLORIDE
- SevereTeva Recalls Trazodone Hydrochloride Tablets Due to Foreign Material
FDA (Drugs) · 2026-09-09
- HighTrazodone tablets recalled over the presence of foreign tablets
FDA (Drugs) · 2026-02-11
- LowTrazodone tablets recalled after complaints of a dent on the tablet surface
FDA (Drugs) · 2026-01-07
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
- 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
- ModerateDicyclomine Hydrochloride Tablets Recalled for Improper Storage Conditions
FDA (Drugs) · 2024-01-03
- HighEstradiol 0.5mg Tablets Recalled Nationwide for Storage Temperature Deviation
FDA (Drugs) · 2024-01-03
- HighDonepezil Hydrochloride Tablets Recalled Due to Storage Temperature Deviations
FDA (Drugs) · 2024-01-03
- HighLithium Carbonate Extended-Release Tablets Recalled for Temperature Excursion
FDA (Drugs) · 2024-01-03