Hikma Pharmaceuticals USA Inc: Alendronate Sodium Oral Solution, 70 Mg/75 Ml
Hikma Pharmaceuticals is recalling Alendronate Sodium Oral Solution (70 mg/75 mL) distributed nationwide because some bottles stored on their side had active ingredient levels outside acceptable ranges. The recall affects a limited number of bottles with NDC 0054-0282-59 that were distributed across all U.S. states and Washington, D.C.
- Recalling firm
- 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
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-04-07
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/bd559c4e-f15f-411a-91fc-63a8879baeef