FDA DrugsClass II
Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single ...
Published: May 6, 2026Recall ID: D-0526-2026Category: drugsCountry: US
Reason for Recall / Hazard
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Columbus |
| State | OH |
| Openfda › Upc | 0300540282592 |
| Openfda › Unii | 2UY4M2U3RA |
| Openfda › Route | ORAL |
| Openfda › Rxcui | 904447 |
| Openfda › Spl id | 56e063a8-8c3d-4445-91fd-0c8806c2b127 |
| Openfda › Brand name | ALENDRONATE SODIUM |
| Openfda › Spl set id | c910bb05-279b-4ffa-a867-46f4a0853ed5 |
| Openfda › Package ndc | 0054-0282-59 |
| Openfda › Product ndc | 0054-0282 |
| Openfda › Generic name | ALENDRONATE SODIUM |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | ALENDRONATE SODIUM |
| Openfda › Manufacturer name | Hikma Pharmaceuticals USA Inc. |
| Openfda › Application number | ANDA090520 |
| Openfda › Is original packager | true |
| Event id | 98744 |
| Address 1 | 1809 Wilson Rd |
| Code info | Lot # AC2040A, Exp Date: 04/2026 |
| Postal code | 43228-9579 |
| Report date | 20260506 |
| Product type | Drugs |
| Product quantity | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260407 |
| Initial firm notification | Letter |
| Center classification date | 20260508 |
Overview
- Recalling FirmHikma Pharmaceuticals USA INC
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide.