April 2026 FDA Recall Alendronate Sodium by Hikma Pharmaceuticals Usa Inc
D-0526-2026 - This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.

This Class II drug recall was voluntarily initiated by Hikma Pharmaceuticals Usa Inc on April 7, 2026 for the product Alendronate Sodium. The FDA reported the reason for recall as this recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0526-2026

Reason for Recall
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Initiated
04-07-2026
Reported
05-06-2026
Quantity
4 single dose 75 ml bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
98744
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hikma Pharmaceuticals USA INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide.
Product Description About Product Description
Full technical description of the product.
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

0054-0282-59 Alendronate Sodium