Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Acetaminophen Injection Recalled by Hikma Pharmaceuticals USA Inc. Due to Labeling: Label Mix-up: a bag of Dexmedetomidine HCl...
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
Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica (Portugal), SA, distributed by Hikma Pharmaceuticals USA Inc Berkeley Heights, NJ NDC 0143-9386-01
Quantity: 31,400 bags
Why Was This Recalled?
Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)
Where Was This Sold?
This product was distributed to 1 state: OH
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