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

TruTrim (product not labeled)

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

Terminated Unapproved drug Novacare, LLC D-0967-2016
Class I · High risk

Prolotherapy with Phenol

Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.

Terminated Sterility / contamination Hartley Medical Center Pharmacy, Incorporated D-1830-2015
Class I · High risk

Prolotherapy with Phenol

Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.

Terminated Sterility / contamination Hartley Medical Center Pharmacy, Incorporated D-1829-2015
Class I · High risk

LiDa DAIDAIHUA

Marketed Without An Approved NDA/ANDA: presence of undeclared Sibutramine and Phenolphthalein.

Terminated Chemical / undeclared Blue Square Market, Inc. D-0296-2016

Recalls by year