Dexamethasone Sodium Phosphate Injection, Solution
FDA Recall NDC 70069-025
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Dexamethasone Sodium Phosphate (NDC 70069-025). A significant event, classified as Class II, was initiated on Feb 04, 2026 by Somerset Therapeutics, Llc. The reported reason for this action was: "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."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
February 2026 Class II Recall: Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities
Recall Number
Class II Ongoing
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.
Feb 04, 2026
Mar 25, 2026
62190 vials
Recall Profile & Regulatory Data
Event ID
98388
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
SOMERSET THERAPEUTICS LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873, NDC carton: 70069-025-10; NDC vial: 70069-025-01
Batch or Lot Expiration Information
Lot# : A240421, Exp 07/31/2026
Affected Packages Involved in this Recall
70069-025-10Product
70069-025-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
