United StatesAlendronate Sodium Oral Solution 70 mg/75 mL in a four-pack of single-dose 75 mL bottles (NDC 0054-0282-59), distributed by Hikma Pharmaceuticals USA Inc., Lot AC2040A, Exp 04/2026, sold nationwide in the US, is being recalled. The recall was initiated because a limited number of bottles that were stored on their side showed out-of-specification assay results.
What's 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.
Recalling firm: Hikma Pharmaceuticals USA INC, Columbus, OH, United States.
How to identify it
Lot # AC2040A, Exp Date: 04/2026
The hazard
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)