Hikma Pharmaceuticals USA INC recalls Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmace…

Recall date

April 7, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0526-2026

FDA classification

Class II

Brand / firm

Hikma Pharmaceuticals USA INC

Sold / distributed

US Nationwide.

Why it was recalled

This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.