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Class II · ModerateActive recall

Alendronate Sodium

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # AC2040A, Exp Date: 04/2026
Where it was soldUS Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byHikma Pharmaceuticals USA Inc.
Brand nameALENDRONATE SODIUM
Generic nameALENDRONATE SODIUM
Active ingredient(s)ALENDRONATE SODIUM
Distributed by / forHikma Pharmaceuticals USA INC
NDC0054-0282-59
Show the full FDA record
Full product labelAlendronate 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.
Recalling firmHikma Pharmaceuticals USA INC
DistributionUS Nationwide.
Quantity4 single dose 75 ml bottles
Recall initiated2026-04-07
Report date2026-05-06
Recall completed—
Recall numberD-0526-2026
ClassificationClass II
FDA statusOngoing
Origin on fileColumbus OH United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.