Source: FDA | Recall date: 05/06/2026
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Affected 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.
Summary: This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Hazard: This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Track your baby products and get automatic recall alerts when something may affect your family.
Learn more about the baby product recall tracker, baby product recall alerts, or recall monitoring plans.