FDAHealthApril 7, 2026
Hikma Pharmaceuticals USA INC — 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
⚠️ This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 7, 2026
US Nationwide.
What's affected?
- 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.
- Brand
- ALENDRONATE SODIUM
- UPC
- 0300540282592
- Lot code
- AC2040A
Additional details
Lot # AC2040A, Exp Date: 04/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 4 single dose 75 ml bottles.
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