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FDARecalled May 6, 2026 · #D-0526-2026

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.

Hazard

Class II — temporary health risk

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Description

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 Distribution: US Nationwide.

Product details

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.
Type
Drugs
Manufacturer
Hikma Pharmaceuticals USA INC
Model numbers
AC2040A
UPCs