Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution Recalled by Pine Pharmaceuticals, LLC Due to Lack of Assurance of Sterility

Date: October 2, 2023
Company: Pine Pharmaceuticals, LLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Pine Pharmaceuticals, LLC directly.

Affected Products

Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Quantity: 2181 droppers

Why Was This Recalled?

Lack of Assurance of Sterility

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Pine Pharmaceuticals, LLC

Pine Pharmaceuticals, LLC has 24 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report