Dexonto 0.4% Dexamethasone Solution Recalled for Incorrect Expiration Dating
Nubratori, Inc. is recalling Dexonto 0.4% dexamethasone sodium phosphate solution because some outer boxes are labeled with an incorrect expiration date (12/25/2025 instead of 12/25/2024), creating risk of use after actual expiration.
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: This is an FDA Class II recall with a labeling error (incorrect expiration date). The source text does not report any illnesses or injuries, and the hazard is a labeling discrepancy rather than contamination or structural defect. This meets the Moderate criteria for labeling errors.
Plain-English summary
Nubratori, Inc. is recalling Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL) due to incorrect labeling on outer boxes. Individual vials are labeled correctly with a beyond-use date (BUD) of 12/25/2024; however, some outer boxes are labeled with an incorrect BUD of 12/25/2025.
This labeling discrepancy creates the potential for the product to be used after its actual expiration date, which could result in loss of product efficacy. The affected product includes lot #C04292401X1 distributed to Pennsylvania and California.
If you have this product, do not use it beyond the correct expiration date of 12/25/2024. Check the individual vial labeling, not the outer box. Consult with your healthcare provider or pharmacist regarding any medication questions or concerns.
The recalled product
- 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 Iontophoresis Use Only, Non-Sterile Product, Not for Injection, NUBRATORI RX, 381 Van Ness Ave# 1507, CA 90501, NDC 71300-6564-1…
- Manufacturer
- Nubratori, Inc
- Affected units
- 20
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 (2)
- Lot #: C04292401X1
- BUD: 12/25/2025 (box).
Distribution
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