Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL recall — FDA D-0526-2026
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Overview of recall records associated with Hikma Pharmaceuticals USA Inc., including dates, categories and classifications where available.
Classification mix: Class II: 1, Class I: 1.
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
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)
This page summarizes recall records in which the official source identifies Hikma Pharmaceuticals USA Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.