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.