FDA recall, , Moderate risk
Somerset Therapeutics Dexamethasone Sodium Phosphate Injection
Dexamethasone Sodium Phosphate Injection failed impurity specifications.
Summary by Recall Canary from the FDA notice
What happened
Somerset Therapeutics LLC, of Somerset, New Jersey, is recalling Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only. The FDA reported the recall began on February 4, 2026, and was added to its Enforcement Report on March 19, 2026.
The product failed impurity specifications, as an out-of-specification impurities result was observed during long term stability testing at product expiry (24 months) for Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.
The product was distributed nationwide in the USA. The recall involves 62190 vials.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the lot code and NDC listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Dexamethasone Sodium Phosphate Injection, USP
- Strength
- 100 mg
- Lot code
- A240421
- Recall number
- D-0398-2026
- NDC
- 70069-025-10
- 70069-025-01
Recall details
- Company began the recall
- Sold in
Nationwide in the USA
- Company
- SOMERSET THERAPEUTICS LLCSomerset, New Jersey
- Hazard
- Drug impurity
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98388
- Recall number
- D-0398-2026
- Quantity recalled
- 62190 vials
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Classified by FDA
Added to FDA's Enforcement Report
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
