Dexpanthenol Injection Solution Recalled for Sterility Assurance Concerns
Red Mountain Compounding Pharmacy is recalling Dexpanthenol 250mg/mL injection solution due to FDA findings that sterility assurance cannot be confirmed. The product was distributed to approximately 494 patients across seven states.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an injectable drug involving sterility assurance failure—a critical manufacturing control issue for parenteral medications. The source text does not report any actual illnesses or injuries, making the hazard theoretical. However, non-sterile injectables pose serious risk of harm including infection and sepsis, which justifies a High severity score at the upper range of what the rubric permits without reported illness.
Plain-English summary
Red Mountain Compounding Pharmacy, operating as First Royal Care Co. LLC, is recalling all lots of Dexpanthenol 250mg/mL injection solution (prescription only) due to lack of assurance of sterility. An FDA inspection identified concerns regarding the manufacturer's ability to ensure the product meets sterility standards required for injectable medications.
The affected product was distributed to approximately 494 patients and consumers who received prescriptions. Distribution occurred across Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. All lots currently within their expiration dates are included in this recall.
Patients who have received this medication should consult their healthcare provider or pharmacist immediately. Individuals should not continue using this product and should seek guidance on alternative treatment options. Healthcare providers should notify their patients who may have received this compounded medication.
For questions about this recall, consumers should contact their pharmacy or healthcare provider, or reach out to the FDA's Division of Drug Recalls at the contact information provided on the FDA's official drug safety website.
The recalled product
- Product
- DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all lots within expiry
Distribution
Part of a larger recall action
This product is one of 40 recalled by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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