FDA Recall D-0398-2026

SOMERSET THERAPEUTICS LLC · Somerset, NJ

Class II Ongoing 99 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

Lot / code: Lot #: A240421, Exp 07/31/2026

Quantity: 62190 vials

Reason for 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: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.

Recall record

Recall number: D-0398-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2026-02-04
Classified by FDA Center: 2026-03-18
FDA published: 2026-03-25
Recalling firm: SOMERSET THERAPEUTICS LLC
Firm location: Somerset, NJ

Drug identification

Brand name(s): DEXAMETHASONE SODIUM PHOSPHATE
Generic name(s): DEXAMETHASONE SODIUM PHOSPHATE
Manufacturer(s): Somerset Therapeutics, LLC
NDC(s): 70069-025
Route(s): INTRAMUSCULAR, INTRAVENOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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