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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-…

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 Medicine & devices FDA May 6, 2026 Reached Texas
Read the official FDA notice →

What to do

Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.

Details

Recalling company
Hikma Pharmaceuticals USA INC — Columbus, OH
Severity
Class II — moderate
Reported
May 6, 2026
Quantity
4 single dose 75 ml bottles
Recall number
D-0526-2026
Status
Ongoing
Source
FDA

Where it went

US Nationwide.

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