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Hikma Injectables USA Inc

Hikma Injectables USA Inc Recalls

All product recalls associated with Hikma Injectables USA Inc.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Dec 2024

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–4 of 4 recalls

Ketamine Injection 50mg (Hikma) – tamper seal issue (2024)

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

Class IIModerate

FDADec 19, 2024Nationwide• Hikma Injectables USA Inc

Phenylephrine Injection (Hikma) – tamper seal issue (2024)

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

Class IIModerate

FDADec 19, 2024Nationwide• Hikma Injectables USA Inc

Fentanyl Injection (Hikma) – Incorrect Barcode (2024)

Labeling: Wrong Barcode

Class III

Low

FDAApr 30, 2024Nationwide• Hikma Injectables USA Inc

Phenylephrine Injection (Hikma) – Label Mix-up (2024)

Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.

Class IHigh

FDAApr 29, 2024CO, GA, PA +2 more• Hikma Injectables USA Inc