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

86 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2018 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

Amlodipine

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Ongoing Nitrosamine impurity Torrent Pharma Inc. D-1145-2018
Class II · Moderate risk

Amlodipine

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Ongoing Nitrosamine impurity Torrent Pharma Inc. D-1144-2018
Class II · Moderate risk

Amlodipine

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Ongoing Nitrosamine impurity Torrent Pharma Inc. D-1143-2018
Class II · Moderate risk

Amlodipine

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Ongoing Nitrosamine impurity Torrent Pharma Inc. D-1142-2018
Class II · Moderate risk

Amlodipine

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Ongoing Nitrosamine impurity Torrent Pharma Inc. D-1141-2018
Class II · Moderate risk

Valsartan Tablets USP

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Ongoing Nitrosamine impurity Torrent Pharma Inc. D-1136-2018
Class II · Moderate risk

Valsartan Tablets USP

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Ongoing Nitrosamine impurity Torrent Pharma Inc. D-1135-2018
Class II · Moderate risk

Valsartan Tablets USP

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Ongoing Nitrosamine impurity Torrent Pharma Inc. D-1134-2018
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 II · Moderate risk

Valsartan Tablets

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Ongoing Nitrosamine impurity A-S Medication Solutions LLC. NDC 54569-6582-0 D-1109-2018
Class II · Moderate risk

Valsartan Tablets

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Ongoing Nitrosamine impurity A-S Medication Solutions LLC. NDC 54569-6583-0 D-1108-2018
Class II · Moderate risk

Valsartan Tablets

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Ongoing Nitrosamine impurity Teva Pharmaceuticals USA NDC 0591-2170-19 D-0989-2018
Class II · Moderate risk

Valsartan Tablets

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Ongoing Nitrosamine impurity Teva Pharmaceuticals USA NDC 0591-2169-19 D-0988-2018
Class II · Moderate risk

Valsartan Tablets

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Ongoing Nitrosamine impurity Teva Pharmaceuticals USA NDC 0591-2168-19 D-0987-2018
Class II · Moderate risk

Valsartan Tablets

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Ongoing Nitrosamine impurity Teva Pharmaceuticals USA NDC 0591-2167-30 D-0986-2018

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