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All product recalls associated with Hikma Pharmaceuticals USA Inc..
Total Recalls
3
Past Year
1
Class I (Serious)
1
Most Recent
Jul 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
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)
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.