Hikma Injectables USA Inc.
FDA 503B outsourcing facility
Dayton, New Jersey
Key Takeaways
- FDA-registered 503B outsourcing facility since 2021
- Sterile compounding from bulk substances: No
- Last FDA inspection: August 8, 2025
- 4 FDA drug recalls on record (2024)
About this facility
A 503B outsourcing facility is registered with the FDA under the Drug Quality and Security Act and may compound sterile medications in bulk without patient-specific prescriptions, under cGMP manufacturing standards. How federal compounding status works.
FDA registration and inspection record
- First registered with FDA
- September 15, 2021
- Most recent registration
- December 29, 2025
- Compounds sterile drugs from bulk substances
- No
- Last FDA inspection
- August 8, 2025
The FDA last inspected Hikma Injectables USA Inc. on August 8, 2025. Investigators issued a Form FDA 483 listing inspectional observations at that visit. The FDA has not yet determined whether further action will be taken.
FDA recall history
Hikma Injectables USA Inc. has 4 FDA drug recalls on record in 2024, based on the FDA enforcement database. Breakdown: 1 Class I, 2 Class II, 1 Class III.
Recall reasons on record include lack of assurance of sterility: the tamper-evident seal on several of the syringes are; labeling: wrong barcode; labeling: label mix-up - ephedrine syringes mislabeled as phenylephrine.
| Date | Class | Product | Reason |
|---|---|---|---|
| December 2024 | Class II | 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 Road, D | Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment. |
| December 2024 | Class II | phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810 | Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment. |
| April 2024 | Class III | Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA I | Labeling: Wrong Barcode |
| April 2024 | Class I | Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Roa | Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine. |
FDA recall classes signal severity, not intent: Class I means a reasonable probability of serious harm, Class II a temporary or reversible risk, Class III a violation unlikely to cause harm. Sterile compounders routinely recall lots as a precaution. FDA definitions.
What this facility compounds
Hikma Injectables USA Inc. reports compounding 8 distinct active ingredients to the FDA Outsourcing Facility Product Report (most recent reporting periods).
- Diltiazem Hydrochloride
- Ephedrine Sulfate
- Glycopyrrolate
- Ketamine Hydrochloride
- Lidocaine Hydrochloride Anhydrous
- Neostigmine Methylsulfate
- Phenylephrine Hydrochloride
- Rocuronium Bromide
Location
36 Stults Rd, Dayton, NJ 08810-1540
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Contact
FDA-registered contact: J. Barton Kalis, 856-489-2247. Source: the facility's FDA outsourcing registration.
License verification
503B outsourcing facilities are also licensed by the state board of pharmacy. Verify the current license status of Hikma Injectables USA Inc. with the New Jersey Board of Pharmacy.
503B facilities in New Jersey
New Jersey has 10 FDA-registered 503B outsourcing facilities in the PeptideGrids directory. See all 503B facilities in New Jersey.
Frequently asked questions
Is Hikma Injectables USA Inc. registered with the FDA?
Yes. Hikma Injectables USA Inc. is a registered 503B outsourcing facility, first registered with the FDA on September 15, 2021 and most recently registered on December 29, 2025.
Has Hikma Injectables USA Inc. been inspected by the FDA?
The FDA last inspected Hikma Injectables USA Inc. on August 8, 2025. A Form FDA 483 was issued.
Has Hikma Injectables USA Inc. had any FDA drug recalls?
Hikma Injectables USA Inc. has 4 FDA drug recalls on record (2024) in the FDA enforcement database.
What does Hikma Injectables USA Inc. compound?
Hikma Injectables USA Inc. reports compounding 8 active ingredients to the FDA.
Where is Hikma Injectables USA Inc. located?
Hikma Injectables USA Inc. is located in Dayton, New Jersey (36 Stults Rd).
Registration and inspection data verified against the FDA list of registered outsourcing facilities on June 6, 2026. Recall history from the FDA openFDA drug enforcement database, retrieved June 6, 2026.
PeptideGrids is independent and not affiliated with, endorsed by, or sponsored by Hikma Injectables USA Inc.. Listings, registration, inspection, and recall data are reported from public FDA records for informational purposes only. A recall or inspection finding is not an accusation of current wrongdoing. This is not medical or legal advice. To request a correction, see our corrections policy.