Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Tobramycin Opthalmic Solution USP Recalled by ALEMBIC PHARMACEUTICALS, INC. Due to Failed Impurities/Degradation Specifications

Date: July 27, 2023
Company: ALEMBIC PHARMACEUTICALS, INC.
Status: Ongoing
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 ALEMBIC PHARMACEUTICALS, INC. directly.

Affected Products

Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05

Quantity: 82,400 bottles

Why Was This Recalled?

Failed Impurities/Degradation Specifications

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About ALEMBIC PHARMACEUTICALS, INC.

ALEMBIC PHARMACEUTICALS, INC. has 2 total recalls tracked by RecallDetector.

Related Recalls

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