Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

150 recalls · Class I, newest first

Class I · High risk

LEADER brand Dry Eye Relief

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

Ongoing Sterility / contamination Cardinal Health Inc. D-0135-2024
Class I · High risk

LEADER brand Dry Eye Relief

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

Ongoing Sterility / contamination Cardinal Health Inc. D-0132-2024
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
Class I · High risk

Artificial Tears

Non-Sterility: FDA analysis found unopened products to have bacterial contamination.

Ongoing Sterility / contamination Global Pharma Healthcare Private Limited NDC 79503-0101-15 D-0919-2023
Class I · High risk

BD ChloraPrep Clear

Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.

Terminated Sterility / contamination CareFusion 213, LLC NDC 54365-400-32 D-0343-2021

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