Pine Pharmaceuticals, LLC
FDA 503B outsourcing facility
Tonawanda, New York
Key Takeaways
- FDA-registered 503B outsourcing facility since 2018
- Sterile compounding from bulk substances: Yes
- Last FDA inspection: November 14, 2025
- 24 FDA drug recalls on record (2015 to 2023)
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
- March 9, 2018
- Most recent registration
- November 19, 2025
- Compounds sterile drugs from bulk substances
- Yes
- Last FDA inspection
- November 14, 2025
The FDA last inspected Pine Pharmaceuticals, LLC on November 14, 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
Pine Pharmaceuticals, LLC has 24 FDA drug recalls on record between 2015 and 2023, based on the FDA enforcement database. Breakdown: 22 Class II, 2 Class III.
Recall reasons on record include lack of assurance of sterility; labeling: incorrect or missing lot and/or exp date: lot code on primary packaging is; cgmp deviations: raw material recalled by repackager, due to discoloration; labeling: label mix-up: brilliant blue g was labeled with an inaccurate auxiliary label; presence of particulate matter: presence of silicone oil microdroplets in bevacizumab.
| Date | Class | Product | Reason |
|---|---|---|---|
| October 2023 | Class II | Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150 | Lack of Assurance of Sterility |
| October 2023 | Class II | Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility |
| October 2023 | Class II | Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx only, Compounded by: Pine Pharmaceuticals 355 River | Lack of Assurance of Sterility |
| October 2023 | Class II | Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkwa | Lack of Assurance of Sterility |
| October 2023 | Class II | Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, | Lack of Assurance of Sterility |
Showing the 5 most recent of 24 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
Pine Pharmaceuticals, LLC reports compounding 32 distinct active ingredients to the FDA Outsourcing Facility Product Report (most recent reporting periods).
- 6-6-Dideuteroglucose
- Atorvastatin Calcium Trihydrate
- Bevacizumab
- Bromfenac Sodium; Moxifloxacin Hydrochloride; Dexamethasone Sodium Phosphate
- Bupivacaine Hydrochloride; Lidocaine Hydrochloride
- Calcium Chloride
- Calcium Gluconate
- Calcium Gluconate Monohydrate
- Ceftazidime
- Cefuroxime Sodium
- Cholic Acid
- Dexamethasone Sodium Phosphate
- Diltiazem Hydrochloride
- Edetate Disodium
- Epinephrine
- Epinephrine; Lidocaine Hydrochloride
- Fentanyl Citrate
- Foscarnet Sodium
- Ketamine Hydrochloride
- Lidocaine Hydrochloride
- Lidocaine Hydrochloride; Oxymetazoline Hydrochloride
- Lidocaine Hydrochloride; Phenylephrine Hydrochloride
- Moxifloxacin Hydrochloride
- Norepinephrine Bitartrate
- Phenylephrine Hydrochloride
- Phenylephrine Hydrochloride; Cyclopentolate Hydrochloride; Tropicamide
- Povidone-Iodine
- Sodium 3-Hydroxybutyrate
- Tropicamide; Phenylephrine Hydrochloride
- Tropicamide; Phenylephrine Hydrochloride; Cyclopentolate Hydrochloride; Ketorolac Tromethamine
and 2 more.
Location
355 Riverwalk Pkwy, N/A, Tonawanda, NY 14150-5837
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Contact
FDA-registered contact: Alfonse Muto, 716-248-1025. 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 Pine Pharmaceuticals, LLC with the New York State Board of Pharmacy.
503B facilities in New York
New York has 2 FDA-registered 503B outsourcing facilities in the PeptideGrids directory. See all 503B facilities in New York.
Frequently asked questions
Is Pine Pharmaceuticals, LLC registered with the FDA?
Yes. Pine Pharmaceuticals, LLC is a registered 503B outsourcing facility, first registered with the FDA on March 9, 2018 and most recently registered on November 19, 2025.
Has Pine Pharmaceuticals, LLC been inspected by the FDA?
The FDA last inspected Pine Pharmaceuticals, LLC on November 14, 2025. A Form FDA 483 was issued.
Has Pine Pharmaceuticals, LLC had any FDA drug recalls?
Pine Pharmaceuticals, LLC has 24 FDA drug recalls on record (2015 to 2023) in the FDA enforcement database.
What does Pine Pharmaceuticals, LLC compound?
Pine Pharmaceuticals, LLC reports compounding 32 active ingredients to the FDA.
Where is Pine Pharmaceuticals, LLC located?
Pine Pharmaceuticals, LLC is located in Tonawanda, New York (355 Riverwalk Pkwy).
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 Pine Pharmaceuticals, LLC. 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.