Dexonto 0.4% recall: Labeling Error
Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), Rx Only, 12 - 5 mL Single Dose Units per box, Preservative Free, For…
Why was Dexonto 0.4% recalled?
Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: C04292401X1, BUD: 12/25/2025 (box).
- Product
- Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), Rx Only, 12 - 5 mL Single Dose Units per box, Preservative Free, For…
- Recalling firm
- Nubratori, Inc
- Quantity
- 20 boxes
- Distribution
- PA and CA.
- Recall date
- May 7, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)