FDAClass II · Drug · Recalled May 6, 2026

Alendronate Sodium Oral Solution recall — Hikma Pharmaceuticals USA INC

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

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0526-2026
Brand: Hikma Pharmaceuticals USA
Classification: Class II
Units affected: 4 single dose 75 ml bottles
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

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.

Affected products

Alendronate Sodium Oral Solution

Companies & origin

Recalling firm location: Columbus, OH, United States
Firm address: 1809 Wilson Rd, 43228-9579

Identifying details (verbatim from the notice)

Product codes / lots: Lot # AC2040A, Exp Date: 04/2026
Distribution: US Nationwide.
Firm notified the public via: Letter
FDA event ID: 98744
Recall initiated: April 7, 2026
FDA classified: May 8, 2026
FDA report date: May 6, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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