Data Composite

Recall D-0526-2026

US Class II Ongoing · initiated 2026-04-07

Recalling firm

Hikma Pharmaceuticals USA INC, OH

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 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.

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