Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Phenylephrine HCI Injection Recalled by Sandoz Inc Due to Lack of Assurance of Sterility: a recent FDA...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sandoz Inc directly.
Affected Products
Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC 66758-016-03), 25 x 5 mL Vials per carton (NDC 66758-016-04) and b) 10 mL Vials, 100 mg/10 mL (NDC 66758-017-01), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
Quantity: a) 1,584 cartons; b) 62,170 vials
Why Was This Recalled?
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sandoz Inc
Sandoz Inc has 30 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report