Hikma Pharmaceuticals USA INC recalls Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceu
Recalled May 6, 2026 · FDA recall D-0526-2026 · Hikma Pharmaceuticals USA
Hazard
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side. · FDA Class II
Units
4 single dose 75 ml bottles
Sold at
US Nationwide.
Description
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
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.
Manufacturer(s)
Hikma Pharmaceuticals USA INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →