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FDAApril 7, 2026drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

hikma pharmaceuticalshikma

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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