FDAClass IIMay 6, 2026

Alendronate Sodium Oral Solution recall

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…

Why was Alendronate Sodium Oral Solution recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # AC2040A, Exp Date: 04/2026

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…
Recalling firm
Hikma Pharmaceuticals USA INC
Quantity
4 single dose 75 ml bottles
Distribution
US Nationwide.
Recall date
May 6, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls