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Home › FDA recalls › PHENYLephrine HCL Infusion
CLASS II · ModerateFDA

Eagle Pharma Outsourcing LLC recalls PHENYLephrine HCL Infusion

📅 Oct 8, 2026 · 📍 Nationwide
Recalling company
Eagle Pharma Outsourcing LLC
Product
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 Riverchase Center, Suite 675, Hoover, AL 35244, UPC: 6985210025. NDC 69852-100-25
Reason
Lack of Assurance of Sterility
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Oct 8, 2026
Reported
Nov 4, 2026
Distribution
Nationwide within the U.S
Status
Ongoing
Quantity
50 250 mL-containers
Lot / codes
Lot: PHENYL100-1004, Expiry: 12/31/2026.
Company location
Hoover, AL
Recall type
Voluntary: Firm initiated
Recall number
D-0105-2027
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0105-2027 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.