Alendronate Sodium Oral Solution recall
Hikma Pharmaceuticals USA INC recalled Alendronate Sodium Oral Solution on May 6, 2026 because of this recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side. It was sold nationwide.
Why it was recalled
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
What's 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.
Quantity: 4 single dose 75 ml bottles
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Hikma Pharmaceuticals USA INC, Columbus, OH
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
US Nationwide. - Status
- Ongoing
- Recall number
- D-0526-2026
- Source
- U.S. Food and Drug Administration
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