Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class I drug recalls - the high-risk category

Class I is the FDA's most serious recall category: a reasonable probability that using the product will cause serious health consequences or death. It is a small share of all recalls, but the one to check first if a medication you take appears here.

1,750 recalls, newest first.

Class I · High risk

Slim-K

Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling and analysis.

Terminated Chemical / undeclared Bethel Nutritional Consulting, Inc D-1207-2015
Class I · High risk

Virginia Hospital Center

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. D-470-2015
Class I · High risk

Bayshore Medical Center

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. D-466-2015
Class I · High risk

Bayshore Medical Center

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. D-465-2015
Class I · High risk

Lankenau Hospital

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

Terminated Sterility / contamination Central Admixture Pharmacy Services, Inc. D-464-2015

Recalls by year