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.

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

Neuroveen

Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia

Terminated Microbial contamination Hellolife D-1201-2018
Class I · High risk

Compulsin

Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia

Terminated Microbial contamination Hellolife D-1200-2018
Class I · High risk

Hydrochlorothiazide Tablets USP

Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg.

Terminated Labeling / mix-up Accord Healthcare, Inc. NDC 16729-182-01 D-1206-2018
Class I · High risk

Montelukast Sodium Tablets 10 mg

Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.

Ongoing Labeling / mix-up Hetero Labs Limited Unit V NDC 31722-726-30 D-0081-2019
Class I · High risk

Levothyroxine and Liothyronine

Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.

Terminated Wrong potency / content Westminster Pharmaceuticals LLC NDC 69367-158-04 D-1182-2018
Class I · High risk

Levothyroxine and Liothyronine

Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.

Terminated Wrong potency / content Westminster Pharmaceuticals LLC NDC 69367-159-04 D-1181-2018
Class I · High risk

Levothyroxine and Liothyronine

Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.

Terminated Wrong potency / content Westminster Pharmaceuticals LLC NDC 69367-155-04 D-1180-2018
Class I · High risk

Levothyroxine and Liothyronine

Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.

Terminated Wrong potency / content Westminster Pharmaceuticals LLC NDC 69367-157-04 D-1179-2018
Class I · High risk

Levothyroxine and Liothyronine

Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.

Terminated Wrong potency / content Westminster Pharmaceuticals LLC NDC 69367-156-04 D-1178-2018
Class I · High risk

Sinus Relief

Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa.

Terminated Microbial contamination Product Quest Manufacturing LLC D-0074-2019

Recalls by year