Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
CALCIUM GLUCONATE INJECTION Recalled by Fresenius Kabi USA LLC (FK USA) Due to Labeling: Missing label
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Fresenius Kabi USA LLC (FK USA) directly.
Affected Products
CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, Rx only, For Direct Slow IV or IV Additive Use Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- Product Code 31110, NDC 63323-311-10
Quantity: 155,900 vials domestically
Why Was This Recalled?
Labeling: Missing label
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fresenius Kabi USA LLC (FK USA)
Fresenius Kabi USA LLC (FK USA) has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report