Yes — there is an active recall. 11 ongoing FDA recalls mention Dexamethasone (81 total). Check the affected lots below.
Most common reason: Sterility / contamination (48 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Dexamethasone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.
Presence of particulate matter - Glass like particles.
Presence of particulate matter - Glass like particles.
Temperature Abuse
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.
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
cGMP deviations: Temperature abuse
cGMP deviations: Temperature abuse
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
CGMP Deviations
Lack of Assurance of Sterility
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.
Lack of Assurance of Sterility
Labeling: Incorrect or missing package insert.
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Lack of Processing Controls
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Lack of Assurance of Sterility
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Lack of Assurance of Sterility
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