Class II

Drug Recall: 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.

Hikma Pharmaceuticals USA INC · April 7, 2026

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.

Distribution

US Nationwide.

States Affected

NATIONWIDE

Quantity Affected

4 single dose 75 ml bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0526-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Hikma Pharmaceuticals USA INC Drug Recall: 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. | SafeCheck