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
- Source
- FDA
- Category
- Drugs & Medications
- Recall ID
- fda-D-0526-2026
- Classification
- Class II
- Recalled
- April 7, 2026
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