Magnesium Chloride Injection Recalled for Sterility Assurance Concerns
Red Mountain Compounding Pharmacy is recalling Magnesium Chloride 200 mg/mL injection because FDA inspection raised concerns about lack of assurance of sterility. The product was distributed to approximately 494 patients in seven states.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The source states FDA inspection raised sterility assurance concerns but does not report any actual illnesses, injuries, or confirmed contamination. This is an FDA Class II recall with no reported adverse events, placing it in the moderate category under the rubric criteria for precautionary recalls without confirmed harm.
Plain-English summary
Red Mountain Compounding Pharmacy, operating as First Royal Care Co. LLC, is recalling Magnesium Chloride 200 mg/mL multiple-dose vial (MDV) injection for prescription use. The recall was initiated because FDA inspection raised sterility assurance concerns about the product.
Approximately 494 patients and consumers who received prescriptions for this product are located in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. The recalled product encompasses all lots within their expiry dates.
Patients who have received this product should contact their healthcare provider or pharmacy for guidance. The FDA classified this as a Class II recall.
The recalled product
- Product
- Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx
- Manufacturer
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Hazard
- sterility-assurance
- injectable-drug
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
Distributed in 7 states:
- AZ
- CA
- FL
- MN
- MT
- TX
- UT
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- ModerateGas-X Simethicone 125 mg softgels recall for incomplete labeling
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27