Hikma Injectables USA recalls

Hikma Injectables USA has 4 recalls on record with the FDA and USDA, the earliest in 2024 and the latest reported on 8 Jan 2025. The most frequent reason is sterility.

Total recalls4since 2024

Last 12 months0reported

Class I125% of total

Ongoing0latest 8 Jan 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 2Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 1 25%Class II 2 50%Class III 1 25%

Why hikma injectables usa is recalled

Product types

By year

2025250%
2024250%

All hikma injectables usa recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
8 Jan 2025Drug	CLASS II	phenylephrine in 9% Sodium Chloride Inj, 1mg per (100 mcg/mL) recalled	Hikma Injectables USA	Sterility	Nationwide
8 Jan 2025Drug	CLASS II	ketamine inj 50 mg recalled by Hikma Injectables USA	Hikma Injectables USA	Sterility	Nationwide
29 May 2024Drug	CLASS I	Phenylephrine in 9% Sodium Chloride Injection Preservative recalled	Hikma Injectables USA	Labeling Errors	5 states
8 May 2024Drug	CLASS III	Fentanyl 1000mcg/ (10mcg/mL) in 9% Sodium Chloride Injection recalled	Hikma Injectables USA	Packaging Defects	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.