Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Eye Drops & Ophthalmic Recalls

Recalls of ophthalmic solutions and eye drops - a category hit by widely reported contamination recalls.

673 recalls in this category, newest first.

Class III · Low risk

Tropicamide 1%

Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper

Ongoing Labeling / mix-up Fagron Compounding Services NDC 71266-8240-01 D-0125-2024
Class I · High risk

Lubricating Tears Eye Drops

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Terminated Sterility / contamination The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0536-1282-94 D-0108-2024
Class I · High risk

Polyvinyl Alcohol 1.4% Lubricating Eye Drops

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Terminated Sterility / contamination The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0536-1325-94 D-0107-2024