Injectable & IV Drugs recalls

The FDA has published 4,606 recalls involving injectable & iv drugs since 2012. The latest was reported on 21 Sep 2026. Most were for sterility. The Compounding Pharmacy of America 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 recalls4,606since 2012
Last 12 months181reported
Class I2465% of total
Ongoing509latest 21 Sep 2026

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 246 5%Class II 4,171 91%Class III 185 4%Other/pending 4

Why injectable & iv drugs is recalled

Companies

Brands

By year

Ongoing injectable & iv drugs recalls

509 active
ReportedClassRecallCompanyReasonWhere
DrugANNOUNCEDICU Medical LLC 9% Sodium Chloride Injection recalledICU Medical LLCOtsuka ICU MedicalPackaging DefectsTX
DrugANNOUNCEDPar Pharmaceutical Dexmedetomidine HCl recalled by Par HealthPar PharmaceuticalPar HealthParticulate MatterNationwide
DrugANNOUNCEDCompounded Glutathione 200 mg/mL multidose vial recalledCentric CompoundingCentric CompoundingPackaging DefectsNationwide
DrugCLASS IICarton label: Mycophenolate Mofetil for injection recalledMycophenolate MofetilMylan PharmaceuticalsSterilityNationwide
DrugCLASS IIVasopressin, in 9% Sodium Chloride Injection per/mL) recalledVasopressin In 0.9% Sodium ChlorideBaxter HealthcareSterilityNationwide
DrugCLASS IIDexmedetomidine Hydrochloride recalled by Baxter HealthcareDexmedetomidine HydrochlorideBaxter HealthcareManufacturing (CGMP) DeviationsNationwide

All injectable & iv drugs recalls, newest first

4,606 total
ReportedClassRecallCompanyReasonWhere
DrugANNOUNCEDICU Medical LLC 9% Sodium Chloride Injection recalledICU Medical LLCOtsuka ICU MedicalPackaging DefectsTX
DrugANNOUNCEDPar Pharmaceutical Dexmedetomidine HCl recalled by Par HealthPar PharmaceuticalPar HealthParticulate MatterNationwide
DrugANNOUNCEDCompounded Glutathione 200 mg/mL multidose vial recalledCentric CompoundingCentric CompoundingPackaging DefectsNationwide
DrugCLASS IICarton label: Mycophenolate Mofetil for injection recalledMycophenolate MofetilMylan PharmaceuticalsSterilityNationwide
DrugCLASS IIVasopressin, in 9% Sodium Chloride Injection per/mL) recalledVasopressin In 0.9% Sodium ChlorideBaxter HealthcareSterilityNationwide
DrugCLASS IIDexmedetomidine Hydrochloride recalled by Baxter HealthcareDexmedetomidine HydrochlorideBaxter HealthcareManufacturing (CGMP) DeviationsNationwide
DrugCLASS IINexterone (amiodarone HCI), 360 mg/ 8 mg/mL) recalledNexteroneBaxter HealthcareSterilityNationwide
DrugCLASS IIDaptomycin, in 9% Sodium Chloride Injection, 500 mg recalledDaptomycin In Sodium ChlorideBaxter HealthcareSterilityNationwide
DrugCLASS IICardene IV (Nicardipine Hydrochloride) recalled by Baxter HealthcareCardene IvBaxter HealthcareManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIDaptomycin, in 9% Sodium Chloride Injection, 1,000 mg recalledDaptomycin In Sodium ChlorideBaxter HealthcareSterilityNationwide

Should you stop taking Injectable & IV Drugs?

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.