Hikma Alendronate Sodium Oral Solution Recall: Out of Specification Assay Results
Hikma Pharmaceuticals recalls 4 x 75 mL Alendronate Sodium Oral Solution bottles with out of specification assay results due to improper storage. Affected lots were stored on side and may not contain correct medication levels.
Lower-risk recall
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Contact the company
What happened, in plain English
Hikma Pharmaceuticals is recalling a limited number of Alendronate Sodium Oral Solution bottles that tested out of specification due to improper storage conditions. This could mean the medication dose is incorrect, potentially affecting treatment effectiveness. Read more at govinfonow.com/recall/31360-hikma-alendronate-sodium-oral-solution-recall-out-of-specification-assay.
Source Summary by GovInfoNow · govinfonow.com/recall/31360-hikma-alendronate-sodium-oral-solution-recall-out-of-specification-assay · Updated August 17, 2026 · FDA enforcement record: FDA #D-0526-2026
Cite this page
“Hikma Alendronate Sodium Oral Solution Recall: Out of Specification Assay Results.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31360-hikma-alendronate-sodium-oral-solution-recall-out-of-specification-assay. Based on FDA recall #D-0526-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0526-2026%22&limit=1).
Why it’s dangerous
The medication was stored on the side instead of upright, causing assay results to be out of specification. This means the actual medication concentration may be incorrect, potentially reducing treatment effectiveness.
Who’s affected
Patients prescribed alendronate sodium for osteoporosis treatment who received the recalled bottles. Those with specific lot numbers and storage conditions are most at risk.
How to tell if you have this one
Check for the product name 'Alendronate Sodium Oral Solution', 70 mg/75 mL, 4 x 75 mL single-dose bottles. The lot number AC2040A with expiration date 04/2026 indicates the affected batch.
- Brand
Hikma- Category
Drug
What to do — step by step
Check Product Details
Verify the product name, lot number AC2040A, and expiration date 04/2026 to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 29 days after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class II
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0526-2026 (April 7, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0526-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.