Oxytocin recalls

The FDA has published 14 recalls involving Oxytocin since 2012. The latest was reported on 15 Oct 2025. Most were for sterility. Nephron Sterile Compounding Center 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 recalls14since 2012
Last 12 months1reported
Class I00% of total
Ongoing2latest 15 Oct 2025

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 12 86%Class III 2 14%

Why oxytocin is recalled

By year

Ongoing oxytocin recalls

2 active

All oxytocin recalls, newest first

14 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIOxytocin for Injection, all strengths and presentations recalledGenoGenixSterilityNationwide
DrugCLASS IIIoxyTOCIN/mL) added to 0.9% Sodium Chloride, Injection recalledQuVa PharmaPackaging DefectsNationwide
DrugCLASS IIOxytocin/mL) in 0.9% Sodium Chloride Injection, USP IV recalledNephron Sterile Compounding CenterSterilityNationwide
DrugCLASS IIOxytocin/mL) in 0.9% Sodium Chloride Injection recalledNephron Sterile Compounding CenterSterilityNationwide
DrugCLASS IIoxyTOCIN/mL) added to 0.9% Sodium Chloride Injection for IV Use recalledQuVa PharmaPotency & AssayNationwide
DrugCLASS IIOxyTOCIN in 0.9% Sodium Chloride Solution (PF) / mL) Single Dose IV recalledKRS Global BiotechnologySterilityNationwide
DrugCLASS IIOxytocin USP, powder-bottle, API American Pharmaceutical Ingredients recalledAmerican Pharmaceutical IngredientsPotency & AssayNationwide
DrugCLASS IIOxytocin in 0.9% Sodium Chloride Solution (PF) IV recalledKRS Global BiotechnologyOtherNationwide
DrugCLASS IIOxytocin in 0.9% Sodium Chloride IV recalledSSM Health Care St. LouisSterilityMO
DrugCLASS IIOxytocin/ml Injection, Multi-Dose Vial, Sterile recalledThe Compounding Pharmacy of AmericaSterilityNationwide
DrugCLASS IIOxytocin Injection, USP, (Synthetic), 10 USP Units/mL recalledFresenius Kabi USAPotency & AssayNationwide
DrugCLASS IIOxytocin/ml Injection, compounded by Olympia Pharmacy, Orlando, FL recalledLowlite InvestmentsSterilityNationwide
DrugCLASS IIOxytocin/ML Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
DrugCLASS IIIPitocin (Oxytocin Injection, USP) Synthetic per mL recalledPitocinJHP PharmaceuticalsPackaging DefectsNationwide

Should you stop taking Oxytocin?

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.