The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0447-2021·Announced 2021-06-02

Cardinal Health Recalls Dexamethasone Sodium Phosphate Eye Drops

Cardinal Health Inc. is recalling 318 droptainers of Dexamethasone Sodium Phosphate 0.1% eye drops due 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, but the source text explicitly states no illnesses or injuries have been reported, and the hazard is a theoretical risk from storage conditions rather than a confirmed high-risk pathogen or structural defect.

Plain-English summary

Cardinal Health Inc. is recalling 318 droptainers of Dexamethasone Sodium Phosphate 0.1% 5ML eye drops. The recall is identified by recall number D-0447-2021 and involves product with code 353351. The affected units were distributed in Florida, Georgia, and South Carolina.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage. The source text does not report any illnesses, injuries, or deaths associated with this recall.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions. The source text does not specify a return address or refund process.

The recalled product

Product
DEXAMETH SOD PHOS 0.1% 5ML; NDC/UPC 24208072002; RX; DROPS
Manufacturer
Cardinal Health Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
318

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)

  • 353351

Distribution

Distributed in 3 states:

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 →

Same hazard · temperature excursion

See all →

Similar recalls