Home / Companies / Pine Pharmaceuticals, LLC

Pine Pharmaceuticals, LLC

FDA Regulatory Profile

Pine Pharmaceuticals, LLC has 24 FDA recalls, 7 inspections, 0 510(k) clearances and 2 compliance actions on record.

Latest recall
D-0059-2024 · Class II · Oct 2, 2023
Latest inspection
Nov 14, 2025 · OAI

Reviewing Pine Pharmaceuticals, LLC as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Pine Pharmaceuticals, LLC yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls24Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections7Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions2Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
D-0059-2024Class IILidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals…Oct 2, 2023
D-0062-2024Class IILidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine…Oct 2, 2023
D-0063-2024Class IITropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only…Oct 2, 2023
D-0054-2024Class IICalcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine…Oct 2, 2023
D-0050-2024Class IIBevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine…Oct 2, 2023
D-0056-2024Class IIMoxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL (150…Oct 2, 2023
D-0052-2024Class IIEndophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine…Oct 2, 2023
D-0060-2024Class IITPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL…Oct 2, 2023
D-0055-2024Class IITropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx…Oct 2, 2023
D-0051-2024Class IIVancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only…Oct 2, 2023
D-0058-2024Class IIMoxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx only…Oct 2, 2023
D-0065-2024Class IIFoscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip…Oct 2, 2023
D-0061-2024Class IICalcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by…Oct 2, 2023
D-0053-2024Class IICalcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine…Oct 2, 2023
D-0064-2024Class IILidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes…Oct 2, 2023
D-0057-2024Class IICefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355…Oct 2, 2023
D-0531-2023Class IIIBevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip tip syringe, each…Mar 27, 2023
D-0130-2023Class IIEpi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, 1 ml, Single…Dec 22, 2022
D-1514-2022Class IIBupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar…Jul 27, 2022
D-0607-2018Class IIIBrilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded by: Pine…Mar 5, 2018

Recent FDA Inspections

DateSiteProductClassificationFEI
Nov 14, 2025Tonawanda, NYDrugsOfficial Action Indicated (OAI)3010943533
Sep 30, 2024Tonawanda, NYDrugsOfficial Action Indicated (OAI)3010943533
Sep 19, 2023Tonawanda, NYDrugsOfficial Action Indicated (OAI)3010943533
May 14, 2021Tonawanda, NYDrugsOfficial Action Indicated (OAI)3010943533
Apr 26, 2018Tonawanda, NYDrugsVoluntary Action Indicated (VAI)3010943533
Oct 9, 2015Tonawanda, NYDrugsOfficial Action Indicated (OAI)3010943533
Oct 17, 2014Tonawanda, NYDrugsNo Action Indicated (NAI)3010943533

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3010943533Tonawanda, NY7Nov 14, 2025

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.