Label Mix-Up Prompts Class I Recall for Injection

Hikma Pharmaceuticals USA Inc. is recalling 31 400 bags of acetaminophen injection after a bag labeled dexmedetomidine HCl injection was found inside an overwrap labeled acetaminophen injection. According to the August 28, 2024, US Food and Drug Administration (FDA) Enforcement Report, the recall has been designated Class I. The classification communicates that use of the injection could cause serious adverse health consequences or death.

“If the provider does not identify the drug inside the acetaminophen overwrap as dexmedetomidine and administers the drug to a patient, there are multiple potential adverse outcomes that may result, including varying degrees of sedation, bradypnea, bradycardia, hypertension, and hypotension, or more serious and potentially life-threatening outcomes,” Hikma Pharmaceuticals PLC stated in a July 22, 2024, company announcement. “To date, Hikma has received one report of an adverse event.”

The recall affects acetaminophen injection, 1000 mg per 100 mL (10 mg/mL), in 100-mL single-dose bags (NDC 0143-9386-01) from lot 24070381 (Exp. 9/30/25). The product was manufactured by Hikma Farmaceutica in Portugal and was distributed in Ohio and Puerto Rico by Hikma Pharmaceuticals USA Inc., Berkeley Heights, New Jersey. 

Hikma Pharmaceuticals USA voluntarily initiated the recall on July 8, 2024. The FDA issued its Class I designation on August 16, 2024.

Acetaminophen injection is indicated for the management of mild to moderate pain in patients 2 years and older, the management of moderate to severe pain with adjunctive opioid analgesics in patients 2 years and older, and for fever reduction in adult and pediatric patients.