FDA Drugs recall ·
PHENYLephrine HCL Infusion, 100 mg per 250 mL in 0.9% Sodium Chloride (0.4… recall
- Recall number
- D-0105-2027
- Date
- (initiated October 8, 2026)
- Company / brand
- Eagle Pharma Outsourcing LLC
2200 Riverchase Ctr Ste 675, Hoover, AL, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 50 250 mL-containers
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Lack of Assurance of Sterility
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: PHENYL100-1004, Expiry: 12/31/2026.
Distribution
Nationwide within the U.S
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0105-2027. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.