Alendronate Sodium Oral Solution Recalled for Out-of-Specification Assay Results
Hikma Pharmaceuticals USA Inc. is recalling Alendronate Sodium Oral Solution 70 mg/75 mL due to out-of-specification assay results found in a limited number of bottles. The affected lot (AC2040A) was distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a drug with out-of-specification assay results in a limited number of bottles. The source text does not report any hospitalizations, illnesses, or injuries, and the hazard is limited to a restricted subset of the lot, making it a moderate-severity precautionary recall rather than high or severe.
Plain-English summary
Hikma Pharmaceuticals USA Inc. is recalling Alendronate Sodium Oral Solution, 70 mg/75 mL (NDC 0054-0282-59) in 4 single-dose 75 mL bottles due to out-of-specification assay results. The recall affects lot AC2040A with expiration date 04/2026, which was distributed nationwide.
A limited number of bottles in this lot were stored on their side and were found to have assay results outside acceptable specifications. Patients taking this medication should not stop taking it without consulting their healthcare provider, but should check if their bottles are from the affected lot.
Consumers who have bottles from lot AC2040A should contact their pharmacy or healthcare provider for guidance. The FDA is investigating the cause of the out-of-specification assay results.
The recalled product
- Product
- ALENDRONATE SODIUM (ALENDRONATE SODIUM)
- Brand
- ALENDRONATE SODIUM
- Manufacturer
- Hikma Pharmaceuticals USA INC
- Hazard
- out-of-specification-assay
- potency-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # AC2040A
- Exp Date: 04/2026
UPCs (1)
- 0300540282592
Distribution
Distributed nationwide across the United States.