Cyclosporine recalls
The FDA has published 13 recalls involving Cyclosporine since 2013. The latest was reported on 27 Sep 2023. Most were for potency & assay. SUN Pharmaceutical Industries 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 13 since 2013
Last 12 months 0 reported
Class I 0 0% of total
Ongoing 0 latest 27 Sep 2023
Recalls per month, last 24 months click a bar for that month Severity split
0 0%9 69%4 31%
Why cyclosporine is recalled
All cyclosporine recalls, newest first 13 total Reported Class Recall Company Reason Where 27 Sep 2023 Drug CLASS III Cequa (cyclosporine ophthalmic solution) 0.09%-Use Vials recalled Cequa SUN Pharmaceutical Industries Potency & Assay Nationwide 5 Oct 2022 Drug CLASS II Neoral soft gelatin capsules (cyclosporine capsules recalled Neoral Novartis Pharmaceuticals Potency & Assay Nationwide 13 Apr 2022 Drug CLASS III Cequa (cyclosporine ophthalmic solution) recalled Cequa SUN Pharmaceutical Industries Particulate Matter Nationwide 26 May 2021 Drug CLASS III Cequa (cyclosporine ophthalmic solution) 0.09%-Use Vials recalled Cequa SUN Pharmaceutical Industries Particulate Matter Nationwide 10 Mar 2021 Drug CLASS III Cequa (cyclosporine ophthalmic solution) 0.09%-Use Vials recalled Cequa SUN Pharmaceutical Industries Potency & Assay Nationwide 28 Feb 2018 Drug CLASS II Cyclosporine USP, for prescription compounding recalled American Pharmaceutical Ingredients Potency & Assay Nationwide 8 Mar 2017 Drug CLASS II CycloSPORINE Capsules, USP, 100 mg blister recalled Cyclosporine Amerisource Health Services Potency & Assay Nationwide 1 Mar 2017 Drug CLASS II CycloSPORINE Capsules, USP, 100 mg recalled by Apotex Cyclosporine Apotex Potency & Assay Nationwide 5 Nov 2014 Drug CLASS II Cyclosporine 200 mg/mL opthalmic suspension recalled Martin Avenue Pharmacy Sterility Nationwide 21 Aug 2013 Drug CLASS II Cyclosporine Ophthalmic, compounded by Pallimed Solutions recalled Pallimed Solutions Sterility Nationwide 10 Jul 2013 Drug CLASS II Cyclosporine 1% ophthalmic drops recalled by Clinical Specialties Clinical Specialties Compounding Pharmacy Sterility FL, GA, SC 10 Jul 2013 Drug CLASS II Cyclosporine 2% ophthalmic, Clinical Specialties recalled Clinical Specialties Compounding Pharmacy Sterility FL, GA, SC 22 May 2013 Drug CLASS II Cyclosporine Injection, all strengths recalled by FVS Holdings FVS Holdings Sterility Nationwide
Should you stop taking Cyclosporine?
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.