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Valsartan And Hydrochlorothiazide
Valsartan And Hydrochlorothiazide recalls: 16 FDA reports
Recalls involving Valsartan And Hydrochlorothiazide. What was wrong with each batch, and how the FDA graded the risk.
16Reports
0Class I
16Ongoing
2019-01-23Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobi
D-0369-2019 · Class II · reported 2019-01-23 · Ongoing
- Why it was recalled
- 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.
- Product
- Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-549-90.
- Where it went
- Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
- How much
- 53,064 bottles
Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurob
D-0366-2019 · Class II · reported 2019-01-23 · Ongoing
- Why it was recalled
- 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.
- Product
- Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-548-90.
- Where it went
- Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
- How much
- 92,616 bottles
Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurob
D-0367-2019 · Class II · reported 2019-01-23 · Ongoing
- Why it was recalled
- 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.
- Product
- Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-551-90.
- Where it went
- Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
- How much
- 111,239 bottles
Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurob
D-0365-2019 · Class II · reported 2019-01-23 · Ongoing
- Why it was recalled
- 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.
- Product
- Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-550-90.
- Where it went
- Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
- How much
- 23,016 bottles
Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurob
D-0368-2019 · Class II · reported 2019-01-23 · Ongoing
- Why it was recalled
- 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.
- Product
- Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-547-90.
- Where it went
- Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
- How much
- 32,160 bottles
Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-coun
D-0332-2019 · Class II · reported 2018-12-19 · Ongoing
- Why it was recalled
- GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
- Product
- Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles (NDC 0378-6325-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
- Where it went
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
- How much
- 32,284 HDPE bottles
Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC 0378-6323-77), (b) 500-coun
D-0330-2019 · Class II · reported 2018-12-19 · Ongoing
- Why it was recalled
- GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
- Product
- Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC 0378-6323-77), (b) 500-count bottles (NDC 0378-6323-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
- Where it went
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
- How much
- 22,813 HDPE bottles
Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-77), (b) 500-co
D-0329-2019 · Class II · reported 2018-12-19 · Ongoing
- Why it was recalled
- GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
- Product
- Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-77), (b) 500-count bottles (NDC 0378-6322-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
- Where it went
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
- How much
- 50,595 HDPE bottles
Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (b) 500-cou
D-0328-2019 · Class II · reported 2018-12-19 · Ongoing
- Why it was recalled
- GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
- Product
- Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (b) 500-count bottles (NDC 0378-6321-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
- Where it went
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
- How much
- 32,696 HDPE bottles
Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Ma
D-0317-2019 · Class II · reported 2018-12-19 · Ongoing
- Why it was recalled
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
- Product
- Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A. NDC 0378-6325-05.
- Where it went
- Product was distributed throughout the United States.
- How much
- 5,660 bottles
Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bottle (NDC 0378-6324-77), (b) 500-co
D-0331-2019 · Class II · reported 2018-12-19 · Ongoing
- Why it was recalled
- GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
- Product
- Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bottle (NDC 0378-6324-77), (b) 500-count bottles (NDC 0378-6324-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
- Where it went
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
- How much
- 19,352 HDPE bottles
Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets, 90-count bottle, Rx Only, Ma
D-0974-2018 · Class II · reported 2018-08-01 · Ongoing
- Why it was recalled
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Product
- Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-313-09
- Where it went
- United States
- How much
- N/A
Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets, 90-count bottles, Rx Only, M
D-0976-2018 · Class II · reported 2018-08-01 · Ongoing
- Why it was recalled
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Product
- Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-315-09
- Where it went
- United States
- How much
- N/A
Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Tablets, 90-count bottle, Rx Only,
D-0975-2018 · Class II · reported 2018-08-01 · Ongoing
- Why it was recalled
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Product
- Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-314-09
- Where it went
- United States
- How much
- N/A
Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Tablets, 90-count bottles, Rx Only,
D-0973-2018 · Class II · reported 2018-08-01 · Ongoing
- Why it was recalled
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Product
- Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-312-09
- Where it went
- United States
- How much
- N/A
Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tablets, 90-count bottles, Rx Only,
D-0972-2018 · Class II · reported 2018-08-01 · Ongoing
- Why it was recalled
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Product
- Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-311-09
- Where it went
- United States
- How much
- N/A
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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