Reported May 6, 2026 · Ongoing
Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma…
Hikma Pharmaceuticals USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hikma Pharmaceuticals USA INC · 1809 Wilson Rd · Columbus, OH · 43228-9579
Is this the product you have?
- Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr
- byHikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59
- Lot codes and dates
- Lot # AC2040A
- Exp Date04/2026
- Amount recalled
- 4 single dose 75 ml bottles
Where it was sold
- Nationwide
Why it was recalled
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
This product could cause temporary or reversible health problems — stop using it.
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