Somerset Therapeutics Dexamethasone Injection Recall: Impurities

This alert was compiled from official government recall data published by the FDA using automated analysis. All facts are sourced directly from official records. Last verified April 11, 2026.

Urgent Recall: Dexamethasone Sodium Phosphate Injection

A medication recall is underway. Somerset Therapeutics, LLC is voluntarily recalling one lot of its Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), due to failed impurities/degradation specifications. This recall impacts U.S. consumers who may have received this injectable medication. It's important to determine if your medication is affected.

The product, a prescription-only corticosteroid injection, is packaged in 10x10 mL Multiple Dose Vials. The affected lot, A240421, has an expiration date of 07/31/2026. The NDC number on the carton is 70069-025-10, while the NDC number on the vial itself is 70069-025-01. The issue was discovered during long-term stability testing, which revealed out-of-specification (OOS) results for certain impurities at the product's expiry (24 months). Specifically, the levels of Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate were found to be above acceptable limits.

This product was distributed nationwide across the United States. While the recall does not specify retailers, it's likely the medication was distributed through hospitals, clinics, and doctor's offices. The recall affects a total of 62,190 vials of the Dexamethasone Sodium Phosphate Injection.

Understanding the Hazard

Nobody wants to find out their medication is potentially compromised. According to the FDA, the issue stems from impurities detected during stability testing. These impurities, Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate, exceeded the acceptable limits at the product's expiry date.

The presence of these impurities raises concerns about the drug's efficacy and potential safety. While the specific risks aren't detailed by the FDA, it's generally understood that unacceptable levels of impurities in medication may lead to unexpected side effects or a reduced therapeutic effect. Because it's an injectable medication, the risk of complications could be higher than with oral medications. It's important for U.S. consumers and their healthcare providers to consider the potential implications of this issue.

What You Should Do Right Now

If you or someone you know may have received an injection from the affected lot, here's what to do:

1. Immediately contact your healthcare provider or the prescribing physician to discuss alternative treatment options and potential risks associated with the affected medication.
2. Check your medication records to determine if you received Dexamethasone Sodium Phosphate Injection from lot A240421, which expires on 07/31/2026.
3. If you have vials from the recalled lot, stop using them immediately and isolate them from other medications to prevent accidental use.
4. Report any adverse reactions or quality problems experienced after receiving the injection to the FDA's MedWatch Adverse Event Reporting program, either online or by downloading and completing the form and submitting it via mail or fax.
5. Contact Somerset Therapeutics, LLC with any questions or concerns regarding the recall.

The Importance of This Class II Recall

The FDA has classified this as a Class II recall. This means that use of or exposure to the recalled product *may* cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. It's a serious matter, and American shoppers need to take it seriously. The FDA issues dozens of recalls each month, and this is one of the most recent.

This recall underscores the importance of rigorous quality control and stability testing in pharmaceutical manufacturing. These types of tests ensure that medications remain safe and effective throughout their shelf life. The discovery of these impurities highlights the potential risks associated with substandard manufacturing processes and the crucial role that regulatory agencies like the FDA play in protecting public health.

About Somerset Therapeutics LLC

Somerset Therapeutics, LLC, based in Somerset, NJ, manufactures and distributes a range of pharmaceutical products. While this recall is specific to Dexamethasone Sodium Phosphate Injection, it's crucial for American shoppers to be aware of the company's responsibilities in ensuring the safety and quality of its medications.

Companies sometimes face challenges in maintaining consistent quality across their product lines. It’s the manufacturer's responsibility to ensure that all medications meet the required safety and efficacy standards. If you're concerned about the quality of medications you're receiving, discussing your concerns with your healthcare provider is always a reasonable step. It's not clear if Somerset Therapeutics has had previous recalls, but the FDA maintains a database of all recalls for public consumption.

Frequently Asked Questions

Q: What exactly is Dexamethasone Sodium Phosphate Injection used for?

It is a corticosteroid used to treat a variety of conditions, including allergic reactions, arthritis, breathing problems (such as asthma), certain blood disorders, and skin diseases.

Q: How do I know if my medication is part of the recall?

Check the label on the vial and carton for the following information: Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Lot #: A240421, Exp 07/31/2026, NDC carton: 70069-025-10, NDC vial: 70069-025-01. If this information matches, your medication is part of the recall.

Q: What are the potential side effects of the impurities found in the recalled medication?

The FDA hasn’t specified the exact side effects. If you have taken the recalled medication, contact your doctor and discuss any adverse effects you are feeling.

Q: What should I tell my doctor if I received the recalled injection?

Inform your doctor that you received Dexamethasone Sodium Phosphate Injection from lot A240421 and discuss any concerns about potential side effects or reduced efficacy. Your doctor can then evaluate your condition and determine the best course of action.

Q: Where can I find more information about this recall?

You can find more information on the FDA's website, including the official recall notice and updates on the situation.

This recall was announced by the U.S. Food and Drug Administration (FDA). For the official notice and complete details, visit www.fda.gov.