Tadalafil recalls

The FDA has published 11 recalls involving Tadalafil since 2020. The latest was reported on 3 May 2023. Most were for manufacturing (cgmp) deviations. Accord Healthcare 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 recalls11since 2020
Last 12 months0reported
Class I00% of total
Ongoing3latest 3 May 2023

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 11 100%Class III 0 0%

By year

Ongoing tadalafil recalls

3 active

All tadalafil recalls, newest first

11 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IITadalafil Tablets, USP 5 mg recalled by Northwind PharmaceuticalsTadalafilNorthwind PharmaceuticalsManufacturing (CGMP) DeviationsNationwide
DrugCLASS IITadalafil Tablets, USP 20 mg recalled by Northwind PharmaceuticalsTadalafilNorthwind PharmaceuticalsManufacturing (CGMP) DeviationsNationwide
DrugCLASS IITadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged recalledRemedyRepackManufacturing (CGMP) DeviationsNationwide
DrugCLASS IITadalafil Tablets, USP, 20 mg recalled by Preferred PharmaceuticalsTadalafilPreferred PharmaceuticalsManufacturing (CGMP) DeviationsNationwide
DrugCLASS IITadalafil Tablets, USP, 5 mg recalled by Accord HealthcareTadalafilAccord HealthcareManufacturing (CGMP) DeviationsPR
DrugCLASS IITadalafil Tablets, USP, 20 mg recalled by Accord HealthcareTadalafilAccord HealthcareManufacturing (CGMP) DeviationsPR
DrugCLASS IITadalafil Tablets, USP, 2.5 mg recalled by Accord HealthcareTadalafilAccord HealthcareManufacturing (CGMP) DeviationsPR
DrugCLASS IITadalafil Tablets, USP 10 mg recalled by Accord HealthcareTadalafilAccord HealthcareManufacturing (CGMP) DeviationsPR
DrugCLASS IITadalafil Tablets, USP 20 mg recalled by Sun Pharmaceutical IndustriesTadalafilSUN Pharmaceutical IndustriesPackaging DefectsNationwide
DrugCLASS IITadalafil Tablets, USP 5 mg recalled by Sun Pharmaceutical IndustriesTadalafilSUN Pharmaceutical IndustriesPackaging DefectsNationwide
DrugCLASS IITadalafil 6 mg Capsule recalled by MPRXMprxHidden Drug IngredientsTX

Should you stop taking Tadalafil?

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.