Fluconazole recalls
The FDA has published 19 recalls involving Fluconazole since 2014. The latest was reported on 8 Aug 2018. Most were for potency & assay. Renaissance Lakewood 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 recalls 19 since 2014
Last 12 months 0 reported
Class I 0 0% of total
Ongoing 0 latest 8 Aug 2018
Recalls per month, last 24 months click a bar for that month Severity split
0 0%14 74%5 26%
Why fluconazole is recalled
All fluconazole recalls, newest first 19 total Reported Class Recall Company Reason Where 8 Aug 2018 Drug CLASS III Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride recalled Renaissance Lakewood Potency & Assay Nationwide 8 Aug 2018 Drug CLASS III Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride recalled Renaissance Lakewood Potency & Assay Nationwide 8 Aug 2018 Drug CLASS III Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride recalled Renaissance Lakewood Potency & Assay Nationwide 25 Apr 2018 Drug CLASS II Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride recalled Renaissance Lakewood Packaging Defects Nationwide 28 Feb 2018 Drug CLASS II Fluconazole USP for prescription compounding recalled American Pharmaceutical Ingredients Potency & Assay Nationwide 27 Dec 2017 Drug CLASS III Fluconazole Injection, USP, 2 mg/mL, a) recalled by Renaissance Lakewood Renaissance Lakewood Potency & Assay Nationwide 24 May 2017 Drug CLASS II Fluconazole Injection, USP, 200 mg recalled by Baxter Healthcare Fluconazole Baxter Healthcare Sterility IL 10 May 2017 Drug CLASS II Fluconazole Tablets, USP, 100 mg Unit Dose recalled Fluconazole The Harvard Drug Group Potency & Assay Nationwide 10 May 2017 Drug CLASS II Fluconazole Tablets, USP, 200 mg Unit Dose recalled Fluconazole The Harvard Drug Group Potency & Assay Nationwide 5 Apr 2017 Drug CLASS II Fluconazole Injection, USP, 400 mg recalled by Claris Lifesciences Claris Lifesciences Sterility Nationwide
Load more (9 more)
Should you stop taking Fluconazole?
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.