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.
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
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.
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.
Patients prescribed alendronate sodium for osteoporosis treatment who received the recalled bottles. Those with specific lot numbers and storage conditions are most at risk.
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.
Verify the product name, lot number AC2040A, and expiration date 04/2026 to confirm if it's affected.
The recall is due to out of specification assay results in a limited number of bottles that were stored on the side.
Check for the product name 'Alendronate Sodium Oral Solution', 70 mg/75 mL, 4 x 75 mL single-dose bottles with lot number AC2040A and expiration date 04/2026.
The recall record does not specify a remedy, so contact Hikma Pharmaceuticals for guidance.
We’ve drafted a message you can send Hikma to request your refund or repair — edit it as you like.
Subject: Recall D-0526-2026 — Hikma Hikma Hello, I own a Hikma that is covered by recall D-0526-2026 from Hikma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
