Notice names this product. Hikma Pharmaceuticals USA’s Alendronate Sodium Oral Solution is named in FDA Class II recall D-0526-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side. Identifying details: Lot # AC2040A, Exp Date: 04/2026. Units affected: 4 single dose 75 ml bottles. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
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.
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Company / brand: Hikma Pharmaceuticals USA recalls
Affected product: Alendronate Sodium Oral Solution recall status
Official ID D-0526-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.