FDA Drug recall D-0526-2026
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., Be…
- FDA Drug
- Class II
- ongoing
- Published 2026-05-06
On 2026-05-06 the FDA classified a Class II recall of 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., Be… by Hikma Pharmaceuticals Usa, citing this recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0526-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-07 |
| Published | 2026-05-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Hikma Pharmaceuticals Usa |
| Distribution | US |
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.
Reason
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Identifiers
| ndc | 0054-0282-59 |
|---|---|
| code_info | Lot # AC2040A, Exp Date: 04/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0526-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.