Why it was recalled
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.
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
Lot numbers, UPCs & expiration codes
Lot #: A240421, Exp 07/31/2026
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0398-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 4, 2026
- FDA report date
- Mar 25, 2026
- Quantity
- 62190 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SOMERSET THERAPEUTICS LLC
Original FDA data
Every field from FDA enforcement report D-0398-2026, exactly as published.
Show all FDA fields
- City
- Somerset
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 98388
- Address
- 300 Franklin Square Dr
- Code information
- Lot #: A240421, Exp 07/31/2026
- Postal code
- 08873-4187
- Report date
- Mar 25, 2026
- Product type
- Drugs
- Recall number
- D-0398-2026
- Classification
- Class II
- Recalling firm
- SOMERSET THERAPEUTICS LLC
- Product 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Feb 4, 2026
- Initial firm notification
- Letter
- Center classification date
- Mar 18, 2026