FreshRecalls

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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

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 23, 2026 at 11:04 PM UTC.

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