FDA recall record · openFDA

Hikma Pharmaceuticals USA INC

5 FDA recalls on record (2023–2026) — 5 drug. 4 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored 1

Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labe 1

Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds 1

Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during r 1

The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual pro 1

Recalls

Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Man Class I 2024-07-08 Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceu Class II 2026-04-07 Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, N Class II 2025-07-22 Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley He Class II 2024-03-12 Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25 Class II 2023-05-11

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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