US Drug Recall Register

FDA Drug Recalls

17,898 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class II · Moderate risk Ongoing

Valsartan Tablets USP 160 mg

Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Aurobindo Pharma USA Inc. NDC 65862-572-90 D-1039-2019
Class II · Moderate risk Ongoing

Valsartan Tablets USP 80 mg

Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Aurobindo Pharma USA Inc. NDC 65862-571-90 D-1038-2019
Class II · Moderate risk Ongoing

Valsartan Tablets USP 40 mg

Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Aurobindo Pharma USA Inc. NDC 65862-570-30 D-1037-2019
Class II · Moderate risk Ongoing

Amlodipine and Valsartan Tablets USP 10mg/160mg

Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Aurobindo Pharma USA Inc. NDC 65862-739-30 D-1036-2019
Class II · Moderate risk Ongoing

Valsartan Tablets USP 320 mg

Reason GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Aurobindo Pharma USA Inc. NDC 65862-573-90 D-1035-2019
Class II · Moderate risk Ongoing

Valsartan tablets USP 320 mg

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Aurobindo Pharma USA Inc. NDC 65862-573-90 D-0370-2019
Class II · Moderate risk Ongoing

Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Aurobindo Pharma USA Inc. NDC 65862-549-90 D-0369-2019
Class II · Moderate risk Ongoing

Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Aurobindo Pharma USA Inc. NDC 65862-547-90 D-0368-2019
Class II · Moderate risk Ongoing

Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Aurobindo Pharma USA Inc. NDC 65862-551-90 D-0367-2019
Class II · Moderate risk Ongoing

Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Aurobindo Pharma USA Inc. NDC 65862-548-90 D-0366-2019
Class II · Moderate risk Ongoing

Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Aurobindo Pharma USA Inc. NDC 65862-550-90 D-0365-2019
Class II · Moderate risk Ongoing

Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Aurobindo Pharma USA Inc. NDC 65862-740-30 D-0364-2019
Class II · Moderate risk Ongoing

Amlodipine and Valsartan Tablets USP 5 mg/320 mg

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Aurobindo Pharma USA Inc. NDC 65862-738-30 D-0363-2019
Class II · Moderate risk Ongoing

Amlodipine and Valsartan Tablets USP 10 mg/160 mg

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Aurobindo Pharma USA Inc. NDC 65862-739-30 D-0362-2019
Class II · Moderate risk Ongoing

Amlodipine and Valsartan Tablets USP 5 mg/160 mg

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Aurobindo Pharma USA Inc. NDC 65862-737-30 D-0361-2019
Class III · Low risk Terminated

Loperamide HCL Tablets USP

Reason Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.

Sun Pharmaceutical Industries, Inc. D-0391-2019
Class II · Moderate risk Terminated

Estradiol Vaginal Inserts

Reason Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator

Glenmark Pharmaceuticals Inc., USA NDC 68462-711-71 D-0350-2019
Class II · Moderate risk Terminated

Nitrofurantoin Oral Suspension

Reason Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.

Lupin Somerset NDC 43386-450-11 D-0346-2019
Class II · Moderate risk Ongoing

LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Torrent Pharma Inc. D-0505-2019
Class II · Moderate risk Ongoing

LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Torrent Pharma Inc. D-0504-2019
Class II · Moderate risk Ongoing

Losartan Potassium Tablets

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Torrent Pharma Inc. D-0503-2019
Class II · Moderate risk Ongoing

Losartan Potassium Tablets

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Torrent Pharma Inc. D-0502-2019
Class II · Moderate risk Ongoing

Losartan Potassium Tablets

Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Torrent Pharma Inc. D-0501-2019
Class III · Low risk Terminated

COSOPT Ophthalmic Solution

Reason Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.

Akorn Inc D-0483-2019
Class II · Moderate risk Completed

Ozurdex

Reason GMP Deviations: A silicone particulate was noted in Ozurdex.

Allergan, PLC. NDC 0023-3348-07 D-0387-2019