Cardinal Health Recalls Travoprost Ophthalmic Solution Due to Temperature Excursions
Cardinal Health Inc. is recalling 325 cartons of Travoprost Ophthalmic Solution 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a CGMP deviation (temperature excursion) without reported injuries or illnesses, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Cardinal Health Inc. is recalling 325 cartons of Travoprost Ophthalmic Solution, USP 0.004%, 2.5mL (NDC 60505-0593-4). The recall was initiated because the product experienced intermittent exposure to temperature excursions during storage, which constitutes a Current Good Manufacturing Practice (CGMP) deviation.
The affected product is a prescription ophthalmic solution distributed in Florida, Georgia, and South Carolina. The specific lot code for the recalled units is RW4409.
Consumers and healthcare providers should check their inventory for this specific lot code and NDC number. If the product is found, it should be quarantined and not used. For further information, contact Cardinal Health Inc. or the FDA.
The recalled product
- Product
- TRAVOPROST (TRAVOPROST)
- Brand
- TRAVOPROST
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Ophthalmic Solution
- Affected units
- 325
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)
- RW4409
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 · TRAVOPROST
- HighEye Drops Recalled: Travoprost Missing Tamper Evidence Seal
FDA (Drugs) · 2023-06-14
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
- ModerateCitalopram Tablets Recalled for Temperature Storage Deviation
FDA (Drugs) · 2024-01-03
- HighWarfarin Sodium Tablets Recalled Due to Temperature Storage Deviation
FDA (Drugs) · 2024-01-03
- HighAlbuterol Sulfate Inhaler Recalled Due to Temperature Storage Deviation
FDA (Drugs) · 2024-01-03
- HighRespiratory inhalation medication recalled for temperature storage deviation
FDA (Drugs) · 2024-01-03