Pramipexole Dihydrochloride recalls

The FDA has published 16 recalls involving Pramipexole Dihydrochloride since 2012. The latest was reported on 18 Sep 2019. Most were for potency & assay. Zydus Pharmaceuticals USA 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 recalls16since 2012
Last 12 months0reported
Class I00% of total
Ongoing0latest 18 Sep 2019

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 11 69%Class III 5 31%

By year

All pramipexole dihydrochloride recalls, newest first

16 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIIPramipexole Dihydrochloride Tablets 0.125 mg recalledPramipexole DihydrochlorideMacleods Pharma UsaPotency & AssayNationwide
DrugCLASS IIPramipexole Dihydrochloride Tablets, 0.25 mg (10 recalledAmerican Health PackagingProcessing DeviationNationwide
DrugCLASS IIPramipexole Dihydrochloride Tablets, 0.5 mg per blister card) recalledAmerican Health PackagingProcessing DeviationNationwide
DrugCLASS IIPramipexole Dihydrochloride Tablets, 1.0 mg per blister card) recalledAmerican Health PackagingProcessing DeviationNationwide
DrugCLASS IIPramipexole Dihydrochloride Tablets, 0.125 mg per blister card) recalledAmerican Health PackagingProcessing DeviationNationwide
DrugCLASS IIPramipexole Dihydrochloride Tablets 1 mg recalledZydus Pharmaceuticals USAManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIPramipexole Dihydrochloride Tablets 0.25 mg recalledZydus Pharmaceuticals USAManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIPramipexole Dihydrochloride Tablets 0.125 mg recalledZydus Pharmaceuticals USAManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIPramipexole Dihydrochloride Tablets 1.5 mg recalledZydus Pharmaceuticals USAManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIPramipexole Dihydrochloride Tablets 0.5 mg recalledZydus Pharmaceuticals USAManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIIPramipexole dihydrochloride extended release tablets, 0.75 mg recalledPar PharmaceuticalPotency & AssayNationwide
DrugCLASS IIIPramipexole Dihydrochloride Extended Release Tablets, 0.375 mg recalledPar PharmaceuticalPotency & AssayNationwide
DrugCLASS IIPramipexole Dihydrochloride Tablets 0.125 mg recalledPramipexole DihydrochlorideMacleods Pharma UsaOtherNationwide
DrugCLASS IIPramipexole Dihydrochloride Tablets, 0.5 mg, Rx recalledShamrock Medical Solutions GroupPackaging Defects5 states
DrugCLASS IIIPramipexole Dihydrochloride Tablets recalled by Sandoz IncorporatedSandozPotency & AssayNationwide
DrugCLASS IIIPramipexole Dihydrochloride Tablets recalled by Sandoz IncorporatedSandozPotency & AssayNationwide

Should you stop taking Pramipexole Dihydrochloride?

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.