Public directory / Facility profile

Hikma Injectables USA Inc., Dayton

NJ · FDA-registered outsourcing facility (503B). A factual public-record profile built from FDA sources, with dates. It is not a ranking, grade, or endorsement.

What the public record shows

FDA 503B registration status

FDA 503B list ✓ (current 2026-08-10)

Hikma Injectables USA Inc., Dayton appears on FDA's registered outsourcing facilities list, parsed from Veritura's capture of that list (FDA list current as of 2026-08-10, captured 2026-08-16). Registration status can change between captures; the FDA page is the authoritative current source.

On our captures

On FDA's list since we began tracking captures on 2026-07-11 (tracking began 2026-07-10; we make no claim about FDA's list before our first capture). Last confirmed on our 2026-08-11 capture (FDA list current as of 2026-08-10).

Dates are Veritura's own capture dates of FDA's public list, shown next to FDA's list-current date wherever we have it. Public-record posture, not a determination.

FDA enforcement timeline

4 dated enforcement records matched this firm name in openFDA when this check last completed.

  • 2024-12-19 · drug · Class II · Terminated
    Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
  • 2024-12-19 · drug · Class II · Terminated
    Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
  • 2024-04-30 · drug · Class III · Completed
    Labeling: Wrong Barcode
  • 2024-04-29 · drug · Class I · Completed
    Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.

Source: openFDA enforcement records (drug/device/food, updated weekly), checked 2026-08-19. Dated public records matching this firm name; similar firm names collide in public records, so confirm the firm identity against the source records before relying. Public-record posture, not a determination.

Live FDA enforcement screen

4 enforcement record matches on this firm name in openFDA when this screen last ran. Review the underlying public records and confirm the firm identity before relying on this signal.

0 FDA compliance action records matched this name.

Source: openFDA enforcement records and FDA compliance dashboards, refreshed at most every 6 hours. A count here documents what public sources returned for this name (searched: Hikma Injectables USA Inc., Dayton); it is not a Veritura determination about the facility.

Reported products

11 distinct products as reported to FDA in 503B product reports (data vintage: reporting periods 2026-1, 2025-2).

  • Diltiazem Hydrochloride · 125 mg/125 mL · injection · reported period 2026-1
  • Ephedrine Sulfate · 50 mg/5 mL · injection · reported period 2026-1
  • Ketamine Hydrochloride · 50 mg/5 mL · injection · reported period 2026-1
  • Ketamine Hydrochloride · 50 mg/1 mL · injection · reported period 2026-1
  • Lidocaine Hydrochloride Anhydrous · 100 mg/5 mL · injection · reported period 2026-1
  • Neostigmine Methylsulfate · 5 mg/5 mL · injection · reported period 2026-1
  • Phenylephrine Hydrochloride · .5 mg/5 mL · injection · reported period 2026-1
  • Phenylephrine Hydrochloride · 1 mg/10 mL · injection · reported period 2026-1
  • Rocuronium Bromide · 50 mg/5 mL · injection · reported period 2026-1
  • Rocuronium Bromide · 100 mg/10 mL · injection · reported period 2026-1
  • Glycopyrrolate · 1 mg/5 mL · injection · reported period 2025-2

Source: FDA outsourcing facility product reports (FD&C 503B(b)(2)). Retrospective by design: a row means the facility reported compounding this product to FDA in the named period, never that it currently compounds, can supply, or is endorsed for it. Public-record posture, not a determination.

Watch this facility

Get an email if this facility's FDA list status or enforcement record changes between our captures. Public-record change notices only; every email carries a one-click unsubscribe link.

Is this your facility?

Claim this profile to keep it accurate and attach your own documentation through Veritura. Every claim is verified by hand before anything changes.

Documented public status from FDA sources. Not an approval, ranking, or endorsement. Veritura does not rank facilities. Dates below show when FDA's list was current and when we captured it, not a Veritura verification of any facility.