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

5 recalls · Class I, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2017 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class I · High risk

Midazolam Injection

Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL

Terminated Labeling / mix-up Fresenius Kabi USA, LLC NDC 76045-001-20 D-0152-2018
Class I · High risk

Pravastatin Sodium Tablets

Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.

Terminated Labeling / mix-up International Laboratories, Inc. NDC 54458-925-16 D-0102-2018
Class I · High risk

EliquisTablets 5mg

Labeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eliquis 2.5 mg tablets only instead of the labeled 5 mg tablets.

Terminated Labeling / mix-up Bristol-myers Squibb Company NDC 0003-0894-21 D-0959-2017
Class I · High risk

Phenobarbital Tablets USP

Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets

Terminated Labeling / mix-up C. O. Truxton NDC 0463-6160-10 D-1111-2017

Recalls by year