Ascorbic Acid Solution Recalled Due to Sterility Assurance Concerns
Red Mountain Compounding Pharmacy is recalling Ascorbic Acid (Non-Corn) 500mg/mL multi-dose solution due to FDA inspection findings regarding lack of sterility assurance. The affected 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall. The hazard—lack of sterility assurance in a multi-dose injectable solution—creates a direct risk of serious infection and potential hospitalization, which meets the Severe category criteria for Class II recalls with significant injury/health risk potential, even in the absence of reported illnesses to date.
Plain-English summary
Red Mountain Compounding Pharmacy, operating as First Royal Care Co. LLC, is recalling all lots of Ascorbic Acid (Non-Corn) 500mg/mL multi-dose solution (Rx only) within their expiration dates. The recall was initiated following an FDA inspection that raised concerns about the sterility assurance of the product.
Approximately 494 patients and consumers who received prescriptions for this product are located in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. Sterility assurance is critical for multi-dose injectable solutions to prevent contamination and infection risk.
Patients who have this product should consult their healthcare provider or pharmacist for guidance. The FDA is working with the recalling firm to ensure appropriate action is taken to protect public health.
The recalled product
- Product
- ASCORBIC ACID (NON-CORN) 500MG/ML MDV 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.
See all 40 products in this recall →Related recalls
Same manufacturer · First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
See all →- SevereMIT/B12 Compounded Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2021-11-03
- HighTestosterone Ultra 250MG/ML Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2021-11-03
- SevereRed Mountain Compounding Test Cypionate Sterility Assurance Recall
FDA (Drugs) · 2021-11-03
- SevereTEST CYP/PROP Compounded Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2021-11-03
- HighTEST CYP 25MG/ML Injectable Lacks Assurance of Sterility
FDA (Drugs) · 2021-11-03
Same hazard · sterility assurance
See all →- SevereSI-BONE iFuse TORQ Implant System Recalled for Sterility Assurance Issues
FDA (Devices) · 2026-10-21
- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2026-07-08
Similar recalls
- SevereRed Mountain Compounding Pharmacy Recalls S-Ascorbic Acid Vials for Sterility Concerns
FDA (Drugs) · 2019-11-13
- SevereBeacon Hill Medical Pharmacy Recalls Ascorbic Acid Injectable Due to Sterility Concerns
FDA (Drugs) · 2013-09-18
- SevereRed Mountain Compounding Pharmacy Recalls Zinc Sulfate Solution Due to Sterility Concerns
FDA (Drugs) · 2019-11-13
- SevereAscorbic Acid Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2021-12-08
- SevereAscorbic Acid Injectable Vials Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SeverePharm D Solutions Recalls Ascorbic Acid Solution Due to Sterility Concerns
FDA (Drugs) · 2018-11-07