Alendronate Sodium Oral Solution — Class II drug recall D-0526-2026
Ongoing recall by Hikma Pharmaceuticals USA INC, reported 2026-05-06, distributed nationwide. This recall is being conducted due to out of specification assay results in a limited number of bottles that w
| Recall number | D-0526-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hikma Pharmaceuticals USA INC, Columbus, OH, United States |
| Recall initiated | 2026-04-07 |
| Classified | 2026-05-08 |
| Reported by FDA | 2026-05-06 |
| Distributed | Nationwide (US) |
| Quantity | 4 single |
| Reason classes | potency, specification failure |
| NDC | 00054-0282, 00054-0282-59 |
| Lot numbers | AC2040A |
| Expiration dates | 2026-04 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0526-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.