FDAFDA · Food and drugs·Recall number D-0526-2026
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.
Published May 6, 2026 · Recall initiated: April 7, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ALENDRONATE SODIUM
- Manufacturer
- Hikma Pharmaceuticals USA INC
- Distributor
- US Nationwide.
- UPC
- 0300540282592
- Lot
- Lot # AC2040A, Exp Date: 04/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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