Recall: D-0526-2026

Class II - Potentially Harmful

Class IIClassification

2026-04-07Initiated

OngoingStatus

Hikma Pharmaceuticals USA INCFirm

Product

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

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.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.