Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx… was recalled on April 7, 2026 in cooperation with the U.S. Food and Drug Administration because this recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side..
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.
Lot # AC2040A, Exp Date: 04/2026
Units affected: 4 single dose 75 ml bottles
Where it was sold: US Nationwide.
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Hikma Pharmaceuticals USA INC
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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