Eagle Pharma oxytocin IV solution recalled over sterility concerns
Eagle Pharma Outsourcing LLC is recalling five 500 mL containers of oxytocin (30 USP units added to 0.9% sodium chloride), lot OXY30-1006, expiration 10/10/2026, distributed nationwide. The FDA classified the recall as Class II because the company cannot assure the product is sterile. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Check whether you have oxytocin with lot number OXY30-1006 and expiration 10/10/2026.
- Do not use or give this product.
- Contact the pharmacy or supplier that provided it for return or disposal instructions.
- Report any problems with this product to the FDA MedWatch program.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- OXYTOCIN, 30 USP UNITS, Added to 0.9% Sodium Chloride 500 mL - Single-Use Container, Rx Only, EAGLE PHARMA OUTSOURCING, 2200 Riverchase Center, Suite 675, Hoover, AL 35244, UPC: 6985203050. NDC 69852-030-50
- Sold in
- Nationwide
- Made for
- Adults (under 0 months)
This recall covers 2 products — see all of them.
Details
- Units affected
- 5 500-mL containers
- Illnesses reported
- None reported
- Manufactured in
- 2200 Riverchase Ctr Ste 675, Hoover, Alabama, United States
- Classification
- Class II
- Recall number
- D-0106-2027
In the FDA's words
- Description
- OXYTOCIN, 30 USP UNITS, Added to 0.9% Sodium Chloride 500 mL - Single-Use Container, Rx Only, EAGLE PHARMA OUTSOURCING, 2200 Riverchase Center, Suite 675, Hoover, AL 35244, UPC: 6985203050. NDC 69852-030-50 Lack of Assurance of Sterility Lot: OXY30-1006, Expiry: 10/10/2026. Distribution: Nationwide within the U.S Affected quantity: 5 500-mL containers
- Hazard
- Lack of Assurance of Sterility
2 products in this recall
Eagle Pharma phenylephrine and oxytocin infusions recalled for sterility risk
Eagle Pharma Outsourcing is recalling two compounded IV infusion products nationwide: phenylephrine HCl (100 mg in 250 mL saline, 50 containers) and oxytocin (30 units in 500 mL saline, 5 containers). The company cannot assure that the products are sterile. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- PHENYLephrine HCL Infusion, 100 mg per 250 mL in 0.9% Sodium Chloride (0.4 mg/mL), Sterile, Rx Only, Single-Use Container, EAGLE PHARMA OUTSOURCING, 2200 Riv…D-0105-2027 · 50 250 mL-containers
- OXYTOCIN, 30 USP UNITS, Added to 0.9% Sodium Chloride 500 mL - Single-Use Container, Rx Only, EAGLE PHARMA OUTSOURCING, 2200 Riverchase Center, Suite 675, Ho… (this page)D-0106-2027 · 5 500-mL containers