Warning
Hikma Pharmaceuticals USA INC Recalls Alendronate Sodium Oral Solution
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0526-2026Drug / Pharmaceutical
Hikma Pharmaceuticals USA INC Recalls Alendronate Sodium Oral Solution
Hikma Pharmaceuticals USA INC · Class II — Moderate Risk
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.
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.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US Nationwide.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A Class II FDA recall has been issued for a pharmaceutical product from Hikma Pharmaceuticals USA INC, initiated on April 7, 2026. This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side. This recall covers 4 single dose 75 ml bottles, distributed in US Nationwide. While not the highest severity, consumers should exercise caution and stop using the product until the recall is resolved.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.