FDA recall D-0526-2026

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.

Distribution

US Nationwide.

Key facts

Status

Ongoing

Initiation date

2026-04-07

Report date

2026-05-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0526-2026