Alendronate Sodium Oral Solution 70 mg/75 mL
Hikma is recalling Alendronate Sodium Oral Solution 70 mg/75 mL (NDC 0054-0282-59) due to out-of-specification assay results.
Do not use this medication if you have a bottle from this recall lot. Contact Hikma Pharmaceuticals USA Inc. or your pharmacy for instructions on returning the product and obtaining a replacement.
Why it was recalled
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
How to identify it
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.
Where it was sold
Distributed in US.
Official source
Editorial summary by Recall Canary · last updated 2026-05-09 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification