Dexamethasone Sodium Phosphate Injection Recalled for Impurity Levels Above Specifications

The US Food and Drug Administration (FDA) has classified a Class II recall for Dexamethasone Sodium Phosphate Injection, USP, 100 mg/10 mL (10 mg/mL), packaged as 10 × 10 mL multiple-dose vials (NDC carton: 70069-025-10; vial: 70069-025-01). The product was manufactured for Somerset Therapeutics, LLC, based in Somerset, NJ, and the recall affects 62 190 vials distributed nationwide in the US. The impacted product is Lot #A240421, with an expiration date of July 31, 2026. The recall was initiated on February 4, 2026.

The recall was prompted by out-of-specification (OOS) impurity results identified during long-term stability testing at product expiry (24 months). Specifically, impurity levels for Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate were found to be above acceptable specifications. The FDA classified the action as Class II on March 18, 2026, indicating that use of the product may cause temporary or medically reversible adverse health consequences, though the likelihood of serious harm is low. Notification was issued to consignees via letter; no public press release has been issued.

Dexamethasone sodium phosphate injection is a corticosteroid indicated for the treatment of a wide range of inflammatory and autoimmune conditions, as well as for allergic reactions, endocrine disorders, and certain oncologic indications. It is commonly used in hospital and acute care settings. Pharmacists should identify and quarantine affected lot A240421, ensure removal from clinical use, and coordinate replacement supply. 

Reference

FDA. Enforcement Report. March 25, 2026. Accessed March 26, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm