Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
methylPREDNISolone Sodium Succinate For Injection Recalled by Hikma Pharmaceuticals USA Inc. Due to Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare...
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
methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA; Dist by: WEST-WARD, Eatontown, NJ 07724, NDC 0143-9850-01.
Quantity: 4840 vials
Why Was This Recalled?
Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.
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