FDA Recalls Calcium Glucosate Injection Due to Microbial Contamination
Specialty Compounding, LLC is recalling Calcium Gluconate 2 gm in 100 mL Sodium Chloride 0.9% for Injection due to non-sterility and microbial contamination.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly identifies the agency classification as 'Class I', which corresponds to the 'Critical' severity level (Score 5) in the rubric.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Calcium Glucosate 2 gm (PF) Preservative Free in 100 mL Sodium Chloride 0.9% for Injection, Rx Only. The product is manufactured by Specialty Compounding, LLC, located in Cedar Park, Texas.
The recall was initiated because the product was found to be non-sterile, indicating microbial contamination. This specific lot is identified by Lot # 07092013M16 with an expiration date of 09/13. The distribution pattern for this product is listed as nationwide.
Consumers and healthcare providers should stop using the affected product immediately. The FDA classifies this as a Class I recall, which is the most serious type of recall, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.
The recalled product
- Product
- CALCIUM GLUCONATE 2 gm (PF) PRESERVATIVE FREE in 100 mL Sodium Chloride 0.9% for Injection, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613
- Manufacturer
- Specialty Compounding, LLC
- Category
- Drug — Injectable Medication
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 (2)
- Lot #: 07092013M16
- Exp 09/13
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Specialty Compounding, LLC 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 2 products in this recall →Related recalls
Same manufacturer · Specialty Compounding, LLC
See all →- SevereSpecialty Compounding Recalls All Prescription Products Due to Sterility Concerns
FDA (Drugs) · 2014-11-05
Same hazard · microbial contamination
See all →- CriticalVictory Medical Center Pharmacy Recalls Glutathione Vials Due to Contamination
FDA (Drugs) · 2026-08-19
- HighMedline Medical Convenience Kits Recalled Due to Potential Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighMedline Convenience Kits Recalled Over Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15