Hikma recalls Alendronate Sodium Oral Solution over out-of-specification test results in some bottles
A limited number of bottles of Alendronate Sodium Oral Solution that were stored on their side had assay test results that were out of specification.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- Product
- 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.
- Hazard
- This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
- Units
- 4 single dose 75 ml bottles
- Where sold
- US Nationwide.
- FDA classification
- Class II · Ongoing
- Classified by FDA
- May 8, 2026
- Recall started
- April 7, 2026
- FDA enforcement report
- May 6, 2026
- Identifiers
- Codes: Lot # AC2040A, Exp Date: 04/2026
- FDA recall number: D-0526-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- 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.
- Reason for recall
- This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
- Classification
- Class II (Ongoing)
- Distribution
- US Nationwide.
- Quantity
- 4 single dose 75 ml bottles
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