Hikma Pharmaceuticals USA Inc.
FDA 503B outsourcing facility
Cherry Hill, New Jersey
Key Takeaways
- FDA-registered 503B outsourcing facility since 2021
- Sterile compounding from bulk substances: Yes
- Last FDA inspection: May 13, 2026
- 19 FDA drug recalls on record (2019 to 2026)
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
- Yes
- Last FDA inspection
- May 13, 2026
The FDA last inspected Hikma Pharmaceuticals USA Inc. on May 13, 2026. No Form FDA 483 was issued at that inspection. The FDA has not yet determined whether further action will be taken.
FDA recall history
Hikma Pharmaceuticals USA Inc. has 19 FDA drug recalls on record between 2019 and 2026, based on the FDA enforcement database. Breakdown: 2 Class I, 15 Class II, 2 Class III.
Recall reasons on record include this recall is being conducted due to out of specification assay results in a limited; failed impurities/degradation specifications: an out-of-specification for total related; labeling: label mix-up: a bag of dexmedetomidine hcl in 0.9% sodium chloride injection; the filter included in the carton has an expiration date that has expired prior to the; failed impurities/degradation specifications: out-of-specification results for total.
| Date | Class | Product | Reason |
|---|---|---|---|
| April 2026 | Class II | Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Ber | This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side. |
| July 2025 | Class II | Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25 | Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds |
| July 2024 | Class I | Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured by: Hikma | Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) |
| March 2024 | Class II | Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC | The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot. |
| May 2023 | Class II | 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), Rx only, Manufact | Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C. |
Showing the 5 most recent of 19 recall events.
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 Pharmaceuticals USA Inc. reports compounding 1 distinct active ingredient to the FDA Outsourcing Facility Product Report (most recent reporting periods).
- Fentanyl Citrate
Location
1809 Wilson Rd, Columbus, OH 43228-9579
Satellite and street imagery via Esri. Open larger map.
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 Pharmaceuticals 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 Pharmaceuticals USA Inc. registered with the FDA?
Yes. Hikma Pharmaceuticals 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 Pharmaceuticals USA Inc. been inspected by the FDA?
The FDA last inspected Hikma Pharmaceuticals USA Inc. on May 13, 2026. No Form 483 was issued.
Has Hikma Pharmaceuticals USA Inc. had any FDA drug recalls?
Hikma Pharmaceuticals USA Inc. has 19 FDA drug recalls on record (2019 to 2026) in the FDA enforcement database.
What does Hikma Pharmaceuticals USA Inc. compound?
Hikma Pharmaceuticals USA Inc. reports compounding 1 active ingredient to the FDA.
Where is Hikma Pharmaceuticals USA Inc. located?
Hikma Pharmaceuticals USA Inc. is located in Cherry Hill, New Jersey (1809 Wilson 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 Pharmaceuticals 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.