Hikma Pharmaceuticals USA INC recalls Alendronate Sodium Oral Solution
- Recalling company
- Hikma Pharmaceuticals USA INC
- 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
- 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 – may cause temporary or medically reversible health consequences
- Recall date
- Apr 7, 2026
- Reported
- May 6, 2026
- Distribution
- US Nationwide.
- Status
- Ongoing
- Quantity
- 4 single dose 75 ml bottles
- Lot / codes
- Lot # AC2040A, Exp Date: 04/2026
- Company location
- Columbus, OH
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0526-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0526-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.