Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only
Recalled by Hikma Pharmaceuticals USA INC
Class II — moderate
Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Hikma Pharmaceuticals USA INC has recalled Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on May 6, 2026 and was initiated on April 7, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, with approximately 4 single dose 75 ml bottles affected. The company behind the recall is Hikma Pharmaceuticals USA INC, based in Columbus, OH. The FDA describes the product as: “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.”
Why was Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only recalled?
According to the FDA, the stated reason for the recall is: “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 you do?
If you think you may have bought Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, compare it against the product description and identifying codes (Lot # AC2040A, Exp Date: 04/2026) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Hikma Pharmaceuticals USA INC or your local health authority.
About this recall
This recall was distributed in OH. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Full recall details
- Status
- Ongoing
- Date reported
- May 6, 2026
- Recall started
- April 7, 2026
- Distributed in
- OH
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only recalled?+
According to the FDA: This recall is being conducted due to out of specification assay results in a limited number of b…
How serious is this recall?+
Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
What should I do if I have Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0526-2026. Information last synced from the FDA on July 5, 2026.