Alendronate Sodium Oral Solution 70 mg/75 mL
Hikma is recalling Alendronate Sodium Oral Solution 70 mg/75 mL (NDC 0054-0282-59) due to out-of-specification assay results.
Do not use this medication if you have a bottle from this recall lot. Contact Hikma Pharmaceuticals USA Inc. or your pharmacy for instructions on returning the product and obtaining a replacement.
Why it was recalled
Hikma Pharmaceuticals USA Inc. is recalling Alendronate Sodium Oral Solution, 70 mg/75 mL (NDC 0054-0282-59, 4 × 75 mL single-dose bottles), due to out-of-specification assay results in a limited number of bottles that were stored on their side.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
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.
- Recall #
- D-0526-2026
Where it was sold
Distributed nationwide.
Official source
Editorial summary by Recall Canary · last updated 2026-05-09 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification