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

86 recalls · Class I, newest first

Class I · High risk

Dr. Ergin's SugarMD

MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide

Ongoing Chemical / undeclared Sugarmds LLC D-0138-2024
Class I · High risk

VITRAKVI (larotractenib)

Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing

Terminated Microbial contamination Bayer Healthcare Pharmaceuticals Inc. NDC 50419-392-01 D-0145-2024
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-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

Phenytoin Oral Suspension

Failed Content Uniformity Specifications

Terminated Wrong potency / content The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-7079-24 D-0153-2024

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