HIGH

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.

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

Quick Facts at a Glance

Recall Date
April 7, 2026
Hazard Level
HIGH
Brands
ALENDRONATE SODIUM, Hikma Pharmaceuticals USA Inc.
Geographic Scope
1 states

Hazard Information

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

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Hikma Pharmaceuticals USA INC or your healthcare provider for guidance. Notification method: Letter

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Full 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.. Generic: ALENDRONATE SODIUM; Brand: ALENDRONATE SODIUM. Reason: This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.. Classification: Class II. Quantity: 4 single dose 75 ml bottles. Distribution: US Nationwide.

Safety Guide

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Product Classification

Product Details

Model Numbers
Lot # AC2040A
Exp Date: 04/2026
UPC Codes
0054-0282
0054-0282-59
Affected States
ALL
Report Date
May 6, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE