# FDA recall D-0526-2026

> **Hikma Pharmaceuticals USA INC** · Class II · drug recall initiated 2026-04-07.

## 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.

## Distribution

US Nationwide.

## Key facts

- **Recall number:** D-0526-2026
- **Recalling firm:** Hikma Pharmaceuticals USA INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-04-07
- **Report date:** 2026-05-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Columbus, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0526-2026

## Citation

> AI Analytics. FDA recall D-0526-2026. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/D-0526-2026. Source: US FDA. Licensed CC0.

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