FDA Drug · 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.

Class II · Ongoing

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

Affected lots / codes — check yours against thisLot # AC2040A, Exp Date: 04/2026

Recalling firm: Hikma Pharmaceuticals USA INC, Columbus, OH
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 4 single dose 75 ml bottles
Distribution: US Nationwide.
Recall initiated: April 7, 2026
Classified: May 8, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0526-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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