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Recall Observatory FDA recall evidence

Drug 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.

D-0526-2026

April 07, 2026

Class II

Product summary

Firm
Hikma Pharmaceuticals USA INC
Event
Event 98744
Status
Ongoing
Classification
Class II
Quantity
4 single dose 75 ml bottles
Official record key
drug-enforcement:D-0526-2026

Official wording

Reason: This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.

Code information: Lot # AC2040A, Exp Date: 04/2026

Distribution pattern: US Nationwide.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification