Public directory / Facility profile

Pine Pharmaceuticals, LLC, Tonawanda

NY · 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 2026-07-14)

Pine Pharmaceuticals, LLC, Tonawanda appears on FDA's registered outsourcing facilities list, parsed from Veritura's capture of that list (FDA list current as of 2026-07-14, captured 2026-07-17). 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 2026-07-17 capture (FDA list current as of 2026-07-14).

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

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

  • 2023-10-02 · drug · Class II · Terminated
    Lack of Assurance of Sterility
  • 2023-10-02 · drug · Class II · Terminated
    Lack of Assurance of Sterility
  • 2023-10-02 · drug · Class II · Terminated
    Lack of Assurance of Sterility
  • 2023-10-02 · drug · Class II · Terminated
    Lack of Assurance of Sterility
  • 2023-10-02 · drug · Class II · Terminated
    Lack of Assurance of Sterility
  • 2023-10-02 · drug · Class II · Terminated
    Lack of Assurance of Sterility
  • 2023-10-02 · drug · Class II · Terminated
    Lack of Assurance of Sterility
  • 2018-03-05 · drug · Class III · Terminated
    Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product.
  • 2015-11-04 · drug · Class II · Terminated
    Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
  • 2015-11-04 · drug · Class II · Terminated
    Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.

Source: openFDA enforcement records (drug/device/food, updated weekly), checked 2026-07-18. 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

10 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: Pine Pharmaceuticals, LLC, Tonawanda); it is not a Veritura determination about the facility.

Reported products

39 distinct products as reported to FDA in 503B product reports (data vintage: reporting periods 2025-2, 2025-1); 20 shown.

  • Atorvastatin Calcium Trihydrate · 20 mg · capsule · reported period 2025-2
  • Atorvastatin Calcium Trihydrate · 40 mg · capsule · reported period 2025-2
  • Bevacizumab · 1.25 mg/.05 mL · injection · reported period 2025-2
  • Bromfenac Sodium; Moxifloxacin Hydrochloride; Dexamethasone Sodium Phosphate · .35 mg/1 mL; 5 mg/1 mL; 1 mg/1 mL · solution · reported period 2025-2
  • Bupivacaine Hydrochloride; Lidocaine Hydrochloride · 3.75 mg/1 mL; 20 mg/1 mL · injection, solution · reported period 2025-2
  • Calcium Chloride · 20 mg/1 mL · injection · reported period 2025-2
  • Calcium Gluconate · 25 mg/1 g · gel · reported period 2025-2
  • Calcium Gluconate · 10 mg/1 mL · solution · reported period 2025-2
  • Calcium Gluconate · 25 mg/1 mL · solution · reported period 2025-2
  • Calcium Gluconate Monohydrate · 25 mg/1 g · gel · reported period 2025-2
  • Dexamethasone Sodium Phosphate · 24 mg/1 mL · injection, solution · reported period 2025-2
  • Diltiazem Hydrochloride · 125 mg/125 mL · injection · reported period 2025-2
  • Edetate Disodium · 15 mg/1 mL · solution · reported period 2025-2
  • Epinephrine · 5 mg/250 mL · injection · reported period 2025-2
  • Epinephrine; Lidocaine Hydrochloride · .25 mg/1 mL; 7.5 mg/1 mL · injection, solution · reported period 2025-2
  • Fentanyl Citrate · 10 ug/1 mL · injection, solution · reported period 2025-2
  • Foscarnet Sodium · 2.4 mg/.1 mL · injection, solution · reported period 2025-2
  • Ketamine Hydrochloride · 2.5 mg/1 mL · injection, solution · reported period 2025-2
  • Lidocaine Hydrochloride · 40 mg/1 mL · solution · reported period 2025-2
  • Lidocaine Hydrochloride; Oxymetazoline Hydrochloride · 20 mg/1 mL; .25 mg/1 mL · solution · 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.

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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.