Quick Facts at a Glance
- Recall Date
- April 7, 2026
- Hazard Level
- HIGH
- Brands
- ALENDRONATE SODIUM, Hikma Pharmaceuticals USA Inc.
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- ALENDRONATE SODIUM, Hikma Pharmaceuticals USA Inc.
- Model numbers
- Lot # AC2040A, Exp Date: 04/2026
- UPC codes
- 0054-0282, 0054-0282-59
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
April 7, 2026
Reported by FDA DRUG
May 6, 2026
RecallRadar source check
May 13, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Hikma Pharmaceuticals USA INC or your healthcare provider for guidance. Notification method: Letter
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Full Description
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.. Generic: ALENDRONATE SODIUM; Brand: ALENDRONATE SODIUM. 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. Quantity: 4 single dose 75 ml bottles. Distribution: US Nationwide.
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Safety Guide
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Read: How to Get Refunds and ReplacementsWant to Know First?
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