FDA recall, , Moderate risk
Eagle Pharma Outsourcing Phenylephrine HCl and Oxytocin Infusions
PHENYLephrine HCL Infusion and Oxytocin lack assurance of sterility.
Summary by Recall Canary from the FDA notice
What happened
Eagle Pharma Outsourcing LLC of Hoover, Alabama, voluntarily recalled PHENYLephrine HCL Infusion and Oxytocin because of a lack of assurance of sterility. The recall began October 8, 2026, and was added to the FDA's Enforcement Report on October 28, 2026. The products were distributed nationwide within the U.S.
The recalled PHENYLephrine HCL Infusion is a sterile, single-use container with 100 mg per 250 mL in 0.9% Sodium Chloride. The recalled Oxytocin is a single-use container with 30 USP units added to 0.9% Sodium Chloride 500 mL. Customers were notified by e-mail.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your container affected?
2 products
Match the lot code and NDC or UPC listed under your product.
A UPC is the number printed under a barcode. An NDC (National Drug Code) is usually printed on the drug's label.
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
- NDC or UPC
- UPC 6985203050
- NDC 69852-030-50
- Lot code
- OXY30-1006
PHENYLephrine HCL Infusion
- Strength
- 100 mg
- NDC or UPC
- UPC 6985210025
- NDC 69852-100-25
- Lot code
- PHENYL100-1004
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Oct 26, 2026
- Sold in
Nationwide within the U.S
- Recalled by
- Eagle Pharma Outsourcing LLCHoover, Alabama
- Hazard
- Sterility problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 100073
- Recall numbers
- D-0105-2027 to D-0106-2027
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
All recalls from Eagle Pharma Outsourcing LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
Eagle Pharma Outsourcing began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
Summary updated
