Recalling firm
Hikma Pharmaceuticals USA INC
Product type
Drug
Status
Ongoing
Report date
2026-05-06
Distribution
US Nationwide.
Firm state
OH
Product quantity
4 single dose 75 ml bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason 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.
Product description
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.
Code / lot info
Lot # AC2040A, Exp Date: 04/2026
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.