Calcium Gluconate recalls

The FDA has published 8 recalls involving Calcium Gluconate since 2013. The latest was reported on 8 Jun 2022. Most were for sterility. Nephron Sterile Compounding Center has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls8since 2013

Last 12 months0reported

Class I113% of total

Ongoing1latest 8 Jun 2022

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 1 13%Class II 6 75%Class III 1 13%

Why calcium gluconate is recalled

Companies

By year

2022113%
2018225%
2017113%
2015113%
2014113%
2013225%

Ongoing calcium gluconate recalls

1 active

Reported	Class	Recall	Company	Reason	Where
11 Jan 2017Drug	CLASS II	Calcium Gluconate 10% Injection recalled by Tri-Coast Pharmacy	Tri-Coast Pharmacy	Sterility	Nationwide

All calcium gluconate recalls, newest first

8 total

Reported	Class	Recall	Company	Reason	Where
8 Jun 2022Drug	CLASS II	Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
7 Nov 2018Drug	CLASS II	Calcium Gluconate 10%, 100 mg/mL Injectable recalled	Pharm D Solutions	Sterility	Nationwide
5 Sep 2018Drug	CLASS II	Calcium Gluconate injectable, 10% Single Dose vial recalled	Auro Pharmacies	Sterility	Nationwide
11 Jan 2017Drug	CLASS II	Calcium Gluconate 10% Injection recalled by Tri-Coast Pharmacy	Tri-Coast Pharmacy	Sterility	Nationwide
9 Dec 2015Drug	CLASS II	Calcium Gluconate 10% Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
16 Apr 2014Drug	CLASS I	Calcium Gluconate 10% for Injection, SDV, PF recalled	Zions RX Formulations Services	Sterility	AZ
11 Dec 2013Drug	CLASS II	Calcium Gluconate 2.5% Gel, Main Street Compounding recalled	Main Street Family Pharmacy	Other	Nationwide
20 Mar 2013Drug	CLASS III	Calcium Gluconate Injection, USP, 10% (100 mg/mL), Single Dose Vial recalled	Fresenius Kabi USA LLC (FK USA)	Labeling Errors	Nationwide

Should you stop taking Calcium Gluconate?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.