FDA recall, , Moderate risk
Hikma Pharmaceuticals Alendronate Sodium Oral Solution
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Summary by Recall Canary from the FDA notice
What happened
Hikma Pharmaceuticals USA INC, based in Columbus, Ohio, recalled Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. The recall was due to out of specification assay results in a limited number of bottles that were stored on side. The product, distributed nationwide, was recalled beginning April 7, 2026, and added to the FDA's Enforcement Report on April 29, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Alendronate Sodium Oral Solution
- NDC
- 0054-0282-59
- Lot code
- AC2040A
Recall details
- Company began the recall
- Sold in
US Nationwide.
- Company
- Hikma Pharmaceuticals USA INCColumbus, Ohio
- Hazard
- Quality testing problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98744
- Recall number
- D-0526-2026
- Quantity recalled
- 4 single dose 75 ml bottles
All recalls from Hikma Pharmaceuticals USA INC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
In FDA's weekly enforcement report
Classified by FDA
Summary updated
