Alendronate Sodium Solution
FDA Recall NDC 0054-0282
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Alendronate Sodium (NDC 0054-0282). A significant event, classified as Class II, was initiated on Apr 07, 2026 by Hikma Pharmaceuticals Usa Inc.. The reported reason for this action was: "This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
April 2026 Class II Recall: This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Recall Number
Class II Ongoing
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Apr 07, 2026
May 06, 2026
4 single dose 75 ml bottles
Recall Profile & Regulatory Data
Event ID
98744
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Hikma Pharmaceuticals USA INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product 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.
Batch or Lot Expiration Information
Lot# AC2040A, Exp Date: 04/2026
Affected Packages Involved in this Recall
0054-0282-59Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
