Oxytocin recalls

The FDA has published 4 recalls involving Oxytocin since 2012. The latest was reported on 15 Oct 2025. Most were for potency & assay. JHP Pharmaceuticals 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 recalls4since 2012

Last 12 months1reported

Class I00% of total

Ongoing1latest 15 Oct 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 1Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 3 75%Class III 1 25%

Why oxytocin is recalled

Companies

By year

2025125%
2018125%
2013125%
2012125%

Ongoing oxytocin recalls

1 active

Reported	Class	Recall	Company	Reason	Where
15 Oct 2025Drug	CLASS II	Oxytocin for Injection, all strengths and presentations recalled	GenoGenix	Sterility	Nationwide

All oxytocin recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
15 Oct 2025Drug	CLASS II	Oxytocin for Injection, all strengths and presentations recalled	GenoGenix	Sterility	Nationwide
21 Mar 2018Drug	CLASS II	Oxytocin USP, powder-bottle, API American Pharmaceutical Ingredients recalled	American Pharmaceutical Ingredients	Potency & Assay	Nationwide
24 Jul 2013Drug	CLASS II	Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL recalled	Fresenius Kabi USA	Potency & Assay	Nationwide
25 Jul 2012Drug	CLASS III	Pitocin (Oxytocin Injection, USP) Synthetic per mL recalledPitocin	JHP Pharmaceuticals	Packaging Defects	Nationwide

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.