FDA Drugs recall ·
Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only… recall
- Recall number
- D-0526-2026
- Date
- (initiated April 7, 2026)
- Company / brand
- Hikma Pharmaceuticals USA INC.
1809 Wilson Rd, Columbus, OH, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4 single dose 75 ml bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # AC2040A, Exp Date: 04/2026
Distribution
US Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0526-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.