Hikma Injectables recalls

3 official recalls and safety alerts involving Hikma Injectables since 2024-05, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Hikma Injectables or the relevant agency.

1. 2025-01-08
2. US
   Drugs & medicalClass II

   Hikma Injectables USA Inc recalls ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults…

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

   FDA · DrugHikma Injectables USA IncNationwide in the USAOfficial notice →
3. 2024-05-29
4. US
   Drugs & medicalClass I

   Hikma Injectables USA Inc recalls Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36…

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

   FDA · DrugHikma Injectables USA IncCO, GA, PA, SD, WAOfficial notice →
5. 2024-05-08
6. US
   Drugs & medicalClass III

   Hikma Injectables USA Inc recalls Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables…

   Labeling: Wrong Barcode

   FDA · DrugHikma Injectables USA IncNationwide within the United StatesOfficial notice →