Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceu
Summary
The FDA issued a Class II for Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single by Hikma Pharmaceuticals USA INC. Reason: This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side..
Details
Source
Drug Recall
External ID
D-0526-2026
Action Date
2026-05-06
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot # AC2040A, Exp Date: 04/2026
Quantity Affected: 4 single dose 75 ml bottles
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.
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-07
Company
Columbus, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 65 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Hikma Pharmaceuticals USA INC has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hikma Pharmaceuticals USA INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hikma Pharmaceuticals USA INC have FDA actions?
Hikma Pharmaceuticals USA INC has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0526-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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