Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sodium Chloride Injection Recalled by Hikma Pharmaceuticals USA Inc. Due to Failed pH Specifications: Out of Specification pH Test...
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 Hikma Pharmaceuticals USA Inc. directly.
Affected Products
Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For use as a sterile diluent, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, a) Vial NDC 0641-0497-17, b) Carton of 25 vials NDC 0641-0497-25.
Quantity: 2,100,646 Vials
Why Was This Recalled?
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Hikma Pharmaceuticals USA Inc.
Hikma Pharmaceuticals USA Inc. has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report