Cardinal Health Recalls SYMPROIC Tablets Due to Temperature Excursions
Cardinal Health Inc. is recalling 67 boxes of SYMPROIC (naldemedine) 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. The hazard involves storage temperature excursions, which is a quality control issue without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cardinal Health Inc. is recalling 67 boxes of SYMPROIC (naldemedine) tablets, 0.2 mg, 30-count bottles. The recall is being conducted due to CGMP deviations involving intermittent exposure to temperature excursions during storage.
The affected product is identified by NDC 59385-041-30 and code 2003060A. The distribution pattern for these units includes Florida, Georgia, and South Carolina.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or physician for guidance. The recall is classified as Class II by the FDA.
The recalled product
- Product
- SYMPROIC (NALDEMEDINE)
- Brand
- SYMPROIC
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 67
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)
- 2003060A
UPCs (1)
- 0359385041307
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 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
- ModerateCitalopram Tablets Recalled for Temperature Storage Deviation
FDA (Drugs) · 2024-01-03
- ModeratePrescription Aripiprazole tablets recalled nationwide for storage temperature deviation
FDA (Drugs) · 2024-01-03
- HighLow-dose aspirin recall due to improper storage temperature conditions
FDA (Drugs) · 2024-01-03
- HighAmoxicillin tablets recalled due to improper storage temperature exposure
FDA (Drugs) · 2024-01-03
- HighWarfarin Sodium Tablets Recalled Due to Temperature Storage Deviation
FDA (Drugs) · 2024-01-03