Cardinal Health Recalls Restasis Eye Drops Due to Temperature Excursions
Cardinal Health Inc. is recalling 3,688 bottles of Restasis 0.05% eye drops 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 due to CGMP deviations (temperature excursions) without reported illnesses or injuries, fitting the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures.
Plain-English summary
Cardinal Health Inc. is recalling 3,688 bottles of Restasis 0.05% ophthalmic solution (NDC 23916330) in 30x0.4 mL and 60x0.4 mL packages. The recall was initiated due to 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 source text does not specify the exact dates of distribution or the specific lot numbers involved, other than the code T1202.
Consumers who have purchased this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- RESTASIS 0.05%30X 0.4ML OPTH PF; NDC/UPC 23916330; RX; DROPS/Restasis 0.05% 60x0.4 mL OPTH PF; NDC/UPC 23916330; RX
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Ophthalmic
- Affected units
- 3,688
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)
- T1202
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.
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