Product: Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59.
Reason for recall: This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Recall initiated: 20260407
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated