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Drug FDA Class II Ongoing Failed specifications

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.

Hikma Pharmaceuticals USA INC Published May 6, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Hikma Pharmaceuticals USA INC or your place of purchase with questions, and see the source record below for full details.
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.

Hazards

Out of Specification Assay · primary

Affected products (1)

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.

ALENDRONATE SODIUM · 4 single dose 75 ml bottles

NDC: 0054-0282, 0054-0282-59
Lot codes: AC2040A
Code info: Lot # AC2040A, Exp Date: 04/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Apr 7, 2026
  2. Published
    May 6, 2026
Recall number
D-0526-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.