FDA Recall D-0526-2026

Hikma Pharmaceuticals USA INC · Columbus, OH

Class II Ongoing 37 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

Lot / code: Lot # AC2040A, Exp Date: 04/2026

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.

Recall record

Recall number: D-0526-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide.
Recall initiated: 2026-04-07
Classified by FDA Center: 2026-05-08
FDA published: 2026-05-06
Recalling firm: Hikma Pharmaceuticals USA INC
Firm location: Columbus, OH

Drug identification

Brand name(s): ALENDRONATE SODIUM
Generic name(s): ALENDRONATE SODIUM
Manufacturer(s): Hikma Pharmaceuticals USA Inc.
NDC(s): 0054-0282
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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