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Medium risk Drugs & MedicationsClass II

Hikma Alendronate Sodium Recall

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., Ber

Updated April 7, 2026

Hikma Pharmaceuticals is recalling Alendronate Sodium Oral Solution due to out-of-specification assay results in some bottles that were stored on their side. The active ingredient strength may be incorrect in affected bottles.

Is the Hikma Pharmaceuticals USA INC recalled? Yes. This product was recalled by FDA on April 7, 2026. Details below.

What is recalled

Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL bottles, 4-pack (NDC 0054-0282-59), distributed by Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922.

Am I affected

You're affected if you have a prescription bottle of Alendronate Sodium Oral Solution 70 mg/75 mL with NDC 0054-0282-59 that was stored on its side or is from a recalled batch from this distributor.

What to do right now

Stop using this medication immediately. Contact your pharmacy or prescribing doctor about your Alendronate Sodium bottle to determine if you have an affected dose and to get a replacement or refill with verified strength.

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.

Brands affected

Hikma Pharmaceuticals USA INC
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0526-2026
Classification
Class II
Recalled
April 7, 2026
Read the official notice

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