Alendronate Sodium Oral Solution recall (Hikma Pharmaceuticals USA INC)
DrugClass IIOngoing
Summary: Hikma Pharmaceuticals USA INC is recalling 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.. Reason: This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
What is being recalled
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
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide.
How to tell if yours is affected
Lot # AC2040A, Exp Date: 04/2026
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0526-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 7, 2026 |
| Reported | May 6, 2026 |
| Company | Hikma Pharmaceuticals USA INC |
| Company location | Columbus, OH, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 4 single dose 75 ml bottles |
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