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.
Recall Number: D-0526-2026
Firm: Hikma Pharmaceuticals USA INC
Classification: Class II
Status: Ongoing
Report Date: 20260506
Initiation Date: 20260407
Termination Date:
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.
Product Description
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.